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Electrician Contractor in West Columbia, SC

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We Keep West Columbia Shining Bright

Electricity - it's one of the most important innovations in the history of humankind. It's hard to imagine life without electricity, and for good reason. Nearly every aspect of our lives is affected by electricity in some form or fashion, from the way you wash your clothes to the effort you put in at work. From a residential standpoint, you need it to cook, clean, entertain, and live comfortably. For commercial purposes, electricity is used to power the computers needed to keep America moving. That's why, when the electricity in your home or at your job is compromised, life grinds to a halt. Unfortunately, electrical problems are inevitable in today's day and age. When the electricity in your home or commercial workspace fails, you need a quick, effective solution that will get your life back on track. And that, in a nutshell, is where L&M Electric, Inc. shines the brightest.

Our company was founded in 2009 by Roger Lee and John Mezzles. With a combined 46 years of electrical experience, the two entrepreneurs set out to create a company that offers quality workmanship and unparalleled service to all its builders and clients. Today, we are proud to have served South Carolina for nearly two decades as the premier electrician contractor in West Columbia, SC. Our family-owned business specializes in both residential and commercial electrical work. Our highly-trained team has the experience and skills to handle any electrical issue, from minor panel breaker problems to large-scale industrial issues.

Despite winning numerous awards and recognitions in the Southeast, we don't let our accolades go to our head. Our team is committed to providing effective, personalized electrical work for every one of our customers. We take pride in our ability to offer peace of mind to our customers when they need it most, and that's exactly what we aim to provide to you too. We're talking one-on-one service provided by a friendly, professional electrician. There are no corners cut, no hidden fees, and no excuses - only the highest quality work from the finest electricians in West Columbia.

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$99 Electrical Home Safety Inspection

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What sets us apart from other electricians in West Columbia, SC? It boils down to three reasons:
Customer-Centric, Quality Electric Service
Customer-Centric, Quality Electric Service

As guests in your home, you won't ever have to worry about a member of our team trying to sell you something you don't need. Our job is to serve your electrical needs. You expect the highest quality electrical work in South Carolina, and that's what we will provide.

Experienced, Affordable Electricians
Experienced, Affordable Electricians

You understand that the highest quality work requires fair compensation, but you're not made of money. Our commitment is to offer affordable electric work at a price you're satisfied paying.

Family Owned & Operated
Family Owned & Operated

We know that you are choosing L&M Electric for a reason. Unlike large corporations, we truly care about our customers. As a family business, serving you is personal for us. We stake our reputation on the quality of our work. As such, we are accountable and will always strive to deliver the service you have come to expect from our company.

Affordable Electric Service That Makes You Feel Like Family

At L&M Electric, we employ the brightest commercial and residential electricians in West Columbia. Having electricians that specialize in both residential and commercial projects allow us to provide our customers with a wider range of services.

Our team fixes a broad range of electrical issues, but we have built our reputation on the following electric services:

 Smart Home Electrician West Columbia, SC

Electrical Repairs

Every homeowner has to deal with an electrical component breaking or failing at some point. When that happens, you need a partner who can troubleshoot the problem and correct the issue efficiently and effectively. A few common problems that we help solve for our customers include:

  • Ceiling Fan Repair
  • Light Fixture Repair
  • Light Switch & Outlet Repair
  • Electrical Safety Inspection
 Smart Home Installation West Columbia, SC

Electrical Installations

Whether you have a new ceiling fan that needs to be installed or you have a new electrical outlet that you'd like added to your bedroom, L&M Electric is here to help. Our team installs quality solutions every day of the week - there's no electrical installation job your residential electrician in West Columbia, SC, can't handle. Here is a glance at some of the installation projects that we complete for homeowners:

  • Smart Home Installation
  • Electric Car Charging Station Installation
  • Whole-Home Surge Protection Installation
 Electrical Repairs West Columbia, SC

Renovations and Remodeling

If you're renovating or remodeling your home, you need a professional electrician on-hand to work to properly install your new electrical devices and systems. Our skilled electricians are happy to work with you or your remodeling consultant to install your lights and keep your home shining bright. Common renovation and remodeling jobs include:

  • Hot Tub Wiring
  • Kitchen Lighting Renovations
  • Finished Basement Electrical Wiring
 Electrical Safety Inspection Company West Columbia, SC

New Construction Electrical Projects

Many new construction homeowners stress about having their electrical system wired from scratch. For us, it's just another day on the job. If you're building your dream home, don't leave your electrical work to mediocre electricians. Trust L&M electric for reliable service and the highest quality electrical work in West Columbia. A few new construction projects we handle are:

  • Breaker Panel Box Installation
  • Wiring for Backup Generator
  • Landscape Lighting Outdoors
  • Low Voltage Wiring
 Whole Home Electrical Install West Columbia, SC

Your Residential Electrician in West Columbia, SC

When you own a home, there's something inherently fulfilling about taking care of your property and fixing issues that pop up over time. When it comes to electrical work, however, DIY projects can be dangerous. Electricity is an amazing innovation, but if you aren't fully trained and licensed to handle such work, it's best to leave it to the experts at L&M Electric. Your home's safety is essential for you and your family. Our team will go above and beyond to ensure that your home's electrical system is operating correctly without any concerning problems.

With more than 60 years of combined experience as electricians, we are capable of troubleshooting and fixing a litany of electrical issues in your house. Keep reading to learn more about the most common electrical issues our customers report, along with some handy tips on how to remediate such problems.

Electrical Services West Columbia, SC

Panel Breaker is Tripped

If you don't have any power in your home, it might be time to check your electrical panel to see if there are any tripped breakers. If you spot a tripped breaker, try your best to switch it over to its original position. If you can't, remember that some breakers need to be flipped to the "off" position before turning it back on. If you don't have any luck, give our office a call. We'll send a trained residential electrician in West Columbia to your home to fix the problem on-site.

 Remodel And Renovation Electrical Work West Columbia, SC

Overhead Fan Stops Working

If you have an overhead fan in your living room or bedroom, you know how quickly it can accumulate dust. Most homeowners clean up using a rod duster. However, sometimes homeowners accidentally hit the fan direction switch when doing so. But, instead of flipping it "on" or "off," they bump it into a limbo zone where neither direction is selected. When this happens, your overhead fan will not spin. If one of your fans stops working suddenly, this is one of the most common reasons why. If you're sure you didn't hit the fan direction switch, it could be an indication of a larger problem. In this case, call our office for a free phone consultation. We'll troubleshoot with you over the phone and if necessary, send out an electrician.

 Electrician West Columbia, SC

Kitchen Breaker Keeps Tripping

If your home was built in the last 35 years, chances are it has two 20-amp circuits running to your kitchen countertop outlets. Newer homes will have three circuits. If you're constantly tripping the breaker to your kitchen, it's most likely because you have too many electrical devices connected to the same circuit. To help alleviate this problem, place appliances like coffee makers and toasters on two different circuits. That way, they can share the load.

At the end of the day, your home is your place of solitude and relaxation. But, when you have electrical issues in your home, things can quickly go from peaceful to problematic. Whether you're renovating your home and need a new room wired for power or your panel breaker keeps giving your problems, L&M Electric is here to assist. If you have questions about an issue or need to schedule service, our team is ready to help answer your questions and coordinate the best time for a residential electrician to come to your home in West Columbia.

 Smart Home Electrician West Columbia, SC

Tips to Save Money and Maintain Your Home's Electrical Systems

Unlike some of our competitors, who are reluctant to provide any information that might prevent them from making a buck, L&M Electric is all about empowering our customers. If we can offer sound advice that will educate our clients and help them save money, we have no problem doing so. That's why we have put together some helpful tips and tricks for maintaining your home's most common electrical systems. Because, at the end of the day, a little knowledge can go a long way when it comes to your family's safety.

 Smart Home Installation West Columbia, SC

Install Surge Protectors

Intense lighting storms can cause powerful surges of electricity that ruin your home's electrical appliances and amenities. Surge protectors installed at your electrical panel can help prevent these surges by grounding the electricity running through your home. They do so by directing it away from your electrical devices. This common solution is inexpensive, effective, and always a better choice than replacing expensive items like TVs and computers.

 Electrical Repairs West Columbia, SC

Examine Your Breaker Panel

Breaker panels control the power to your home. When they go bad or are damaged, there's a good chance that you will lose power to most of the rooms in your house. Open your breaker panel and keep a sharp eye out for signs of corrosion and rust. Double-check that each breaker you see flips on and off properly. If you notice corrosion or if the breaker switches won't flip, it's time to get in touch with a residential electrician in West Columbia, SC, who can inspect your breaker panel and recommend upgrades if necessary.

 Electrical Safety Inspection Company West Columbia, SC

Test Your GFIs

GFIs, or Ground Fault Interrupters, are similar to surge protectors in that they prevent electrical damage from happening in your home. The primary job of a GFI is to prevent electrical shocks that happen during a ground fault. Because water is a conductor of electricity, GFIs should be installed anywhere that an outlet comes into contact with water. You should try to test your GFIs every month, if possible, to ensure that they are working correctly. When you look closely at your GFI, you will notice a "test" and a "reset" button. Hit the "test" button to trip the GFI outlet and then hit "reset" to restore power. If your outlet resets, your GFI is working as it should. If not, you need to replace your GFI outlet. Because electricity is involved, we recommend hiring a professional to install new GFIs in your home. That way, you know the job is done right.

 Whole Home Electrical Install West Columbia, SC

Replace Outdated Light Bulbs

The right light bulb can add the perfect amount of ambiance to your home. Eventually, however, even the best light bulbs will need replacing. While they don't need checking every month, it's a good idea to inspect all your bulbs at the beginning of the year. If any of your bulbs are dead, you should replace them. You should also consider replacing bulbs that are incandescent with LED lights. LED light bulbs may cost more upfront but use less electricity and are more efficient over the long run.

Electrical Services West Columbia, SC

Schedule a Home Safety Inspection

In terms of preventative maintenance, scheduling a safety inspection for your home's electrical systems should be a high priority. These inspections will shine a light on the electrical features in your home that need to be fixed. Most modern electrical fires are caused by short circuit arcs, defective insulation, or broken wiring. An inspection conducted by a qualified electrician will help determine what needs to be fixed so you and your family stay safe in your home. Your inspector should cover your whole home and will examine common features such as:

  • Breakers
  • Fans
  • Exposed Wiring
  • Electrical Panels
  • Circuits
  • Switches
  • Outlets and More
 Remodel And Renovation Electrical Work West Columbia, SC

DELIVERING QUALITY ELECTRICAL SERVICE TO 5,000+ HOMES PER YEAR

he electrical system in your home brings it to life from the lights and appliances we use every day to the entertainment we all love and enjoy. You want an electrician that makes you feel safe while delivering the quality services you're promised.

ELECTRICIAN SERVICE REQUEST

Full-Service Electrical Work for Home and Business

Whether you need light switch services for your newly renovated home or need a generator installed at your commercial property, L&M Electric is here to serve you. Our team will get the job done right, so you can get back to loving your life in the Lowcountry.

Coantact Us
 Electrician West Columbia, SC

Latest News in West Columbia, SC

FDA writes warning to Nephron, calls response to violations ‘inadequate’

WEST COLUMBIA, S.C. (WIS) - The FDA filed a letter warning a West Columbia pharmaceutical company to correct violations or it may face seizure or injunction.Nephron Pharmaceutical has been under observation over the last year by the regulatory body. It has issued several recalls, impacting millions of units.PREVIOUS COVERAGEThe latest letter is dated Oct. 11 and addresses Lou W. Kennedy, the Chief Executive Officer and Owner of the company. The letter says the FDA inspected the facility at 4500 12th St from March ...

WEST COLUMBIA, S.C. (WIS) - The FDA filed a letter warning a West Columbia pharmaceutical company to correct violations or it may face seizure or injunction.

Nephron Pharmaceutical has been under observation over the last year by the regulatory body. It has issued several recalls, impacting millions of units.

PREVIOUS COVERAGE

The latest letter is dated Oct. 11 and addresses Lou W. Kennedy, the Chief Executive Officer and Owner of the company. The letter says the FDA inspected the facility at 4500 12th St from March 28 to April 20 this year and is reviewing the company’s response from May 11.

The letter says there were several violations observed.

1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

In the first violation subsection, the FDA wrote, “Your firm failed to conduct adequate and timely investigations relating to products made by both terminal sterilization and aseptic processing.”

It says Nephron testing found cross-contamination in at least three lots of drug products. The FDA said, “You failed to adequately identify the root cause or scope of potentially impacted lots in a timely manner.”

The FDA wrote that Nephron attributed the root cause to sterilization cycles and permeability on the container closure system used in production.

The FDA warned, “It is essential that your firm does not introduce risks through overlap of your outsourcing and conventional production operations by sharing equipment, facilities, processes, or personnel, as the applicable standards significantly differ in certain respects. The attempt to mix these operations and follow two different standards increases complexity and product hazards.”

Another investigation was opened on April 30, 2021, and remained open at the time of the FDA inspection on March 28, 2022. The FDA said the company continued to manufacture drug products with the same container system.

They said of Nephron’s conclusions, “Your response is inadequate. Your investigation does not consider other sources of contamination. With only limited data, you conclude that the measured level of cross-contamination was “negligible.”

2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

In the second violation subsection, the FDA leads their warning with, “You did not establish appropriate environmental monitoring (EM) action levels for the ISO 5 critical area where drugs are most vulnerable to contamination.”

The FDA notes that Nephron revised its action levels for air, surface, and personnel monitoring. The organization again says, “However, your response is inadequate...”

3. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

In the third violation subsection, the FDA tells Nephron, “You failed to demonstrate that the method used for sample collection for EM (e.g., use of tubing with a length of about (b)(4) and material) provides a meaningful and representative sample of conditions during production.”

The letter details the use of tubing and says Nephron’s response, “...You provide rationale for the sampling procedure and agree that the sampling should be collected as close to the point of fill as possible without impacting the airflow within the blow fill seal machine environment.”

The FDA highlights for a third time, “Your response is inadequate because, you did not provide supportive studies evaluating whether your sampling method is capable of adequality monitoring your ISO 5 environment as intended.”

FDA’S RECOMMENDATIONS AND CONCLUSIONS

The FDA recommended Nephron work with a qualified consultant to insure it is in compliance with FDA regulations.

The administration wrote that Nephron had recalled Ketorolac Tromethamine Injection after a phone call from the FDA on Aug. 2. This was in addition to four outsourcing facilities compounding drug products. Nephron planned to resume operations on Aug. 23.

The FDA said “Resumption of manufacturing your drugs terminally sterilized by moist heat should only occur once you have implemented effective CAPA and completed appropriate submission requirements.”

The FDA said their inspection indicated Nephron is in violation of Field Alert reporting requirements. Specifically, it notes a violation on April 2, 2021, and on May 27, 2022,

“We are concerned with the CGMP violations demonstrated at your facility and failure to submit FAR-related events within three days of becoming aware of a problem. Please include in your written response the corrective action you plan to take regarding distributed products manufactured at your facility that may be affected by the violations.”

The FDA said the violations highlighted in the letter are not an all-inclusive list of violations at the Nephron facility. It advised the company it is responsible for investigating violations and preventing future instances.

It warned Nephron, “Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.”

Nephron has 15 days from the date of receiving the letter to respond and specify what they have done to prevent future issues.

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TC Veterans You Need to Know

Meet members of the TC community who served in the U.S. military — and learn what motivates them — in honor of Veteran’s DayTraveling far from home and embarking on missions in the face of danger are just some of the ways through which military personnel make sacrifices. But after and during service, some veterans find themselves on 120th Street.Teachers College carries military ties in multiple ways: through the Resilien...

Meet members of the TC community who served in the U.S. military — and learn what motivates them — in honor of Veteran’s Day

Traveling far from home and embarking on missions in the face of danger are just some of the ways through which military personnel make sacrifices. But after and during service, some veterans find themselves on 120th Street.

Teachers College carries military ties in multiple ways: through the Resilience Center for Veterans and Families, which promotes mental health through research and clinical training; and the Eisenhower Leader Development Program, a partnership between TC and the U.S. Military Academy that offers officers a slightly modified master’s in social-organizational psychology.

But during this special time, join us in saluting service members and meet just a few of the veterans in the Teachers College community.

Shevez Freeman (M.A. ’22, Higher and Postsecondary Education)

An instructor at the United States Military Academy in West Point, NY, Major Freeman has embarked on a military career that includes two tours in Iraq. She began her teaching career when guiding cadets through basic training and went on to become an Assistant Professor of Military Science in the ROTC program at UCLA.

Why She Served: Freeman enlisted in the military shortly after the September 11th attacks in 2001, which shook the country when Freeman was just in high school. “I decided I wanted to help.”

What She’s Passionate About: Connecting with young people and making the military more inclusive for everyone, explains Freeman, who found that at TC, social justice was “embedded in every single course.”

“I thought I would learn to become a better teacher,” says the major. “But talking so much about social justice taught me to look at the big picture – knowledge I can use to raise awareness at West Point.”

What’s Next: This semester, Freeman is teaching a military science course at West Point, where she hopes to continue to teach. The TC grad — a mom and fitness enthusiast — will continue active duty until 2026.

Peter Kim (Ed.D. ’22, Applied Linguistics)

A veteran decorated with a Purple Heart and Bronze Star medal, Kim served as an Army officer in the 1st Cavalry Division stationed in Fort Hood, Texas. His four years of service also included a stint in Iraq as a Mechanized Infantry Platoon Leader.

Why He Served: Kim always aspired to join the military and give back. “You experience so much during your service and the values you learn stay with you throughout your life. It has shaped me into who I am today,” explains Kim, who joined up after graduating from the University of Michigan in 2002. “My service has taught me the value of sacrifice, serving others and being able to muster strength in difficult times.”

What He’s Passionate About: After learning English as an immigrant to the United States in his youth, Kim has dedicated his career to teaching and studying language. “TC has been the perfect intersection where theory meets practice, a place to truly learn the latest and the most exciting state-of-the art trends in education and applied linguistics,” explains Kim, who now serves as a senior researcher for the Occupational English Test. “I think there is something powerful and deeply mysterious about language and also the depth of communication language allows.”

Irene Trowell-Harris (Ed.M., Ed.D. ’83, Health Education )

A lifelong leader in healthcare for veterans, Major General Trowell-Harris served as the director of the federal Department of Veterans Affairs for 12 years. She began her 38-year military career as a flight nurse in the New York Air National Guard, , serving as Chief Nurse Executive, Flight Nurse Examiner and Commander. By 1993, she was the first Black woman in the history of the National Guard promoted to Brigadier General and subsequently promoted to Major General in 1998.

Why She Served: The niece of World War II veterans, Trowell-Harris began aspiring to military service when, one day while picking cotton with her 10 brothers and sisters in South Carolina, she watched as a plane flew overhead. “I said, ‘One day, I’m going to be up there,’” she recalled in a 2013 conversation with TC.

What She’s Passionate About: At the intersection of public health and service, Trowell-Harris views her contributions beyond military accolades. “The true value of my accomplishments must be in using them to benefit society – specifically, college students, family, church, community, state and country,” said Trowell-Harris, a dedicated supporter of financial aid through the TC Promise scholars initiative. “My greatest joy in life is mentoring and helping others to become successful and achieve their potential as leaders for the next generation.”

In 1999, a mentoring award was named in her honor at the 105th Airlift Wing, Newburgh, NY and in 1998, she became the first woman in history to have a Tuskegee Airmen Chapter, Inc. named in her honor: the Major General Irene Trowell-Harris Tuskegee Airmen, Chapter, Inc. Newburgh, NY.

Daniel Morton (Ed.D. student, Clinical Psychology)

Morton served in the military for six years.

What He’s Passionate About: Dedicated to supporting mental health among service members, Morton is currently immersed in his doctoral studies and his work at the Harlem Vet Center, where he helps match former service members in school with work-study opportunities related to their scholarship.

Morton spoke with Columbia University Neighbors last year about how his service has informed his passion for helping others. “I would say my biggest takeaway from the military is you can connect with all types of different people as long as you're willing to put in the effort,” Morton explained.

What’s Next: Morton is on a new mission to become a clinical psychologist with the eventual aim of “revamp[ing] the behavioral health program in the Army.”

Jamie Hickman (Ed.D. student, M.Ed., Adult Learning and Leadership)

Hickman is an active duty U.S. Army Major with the Headquarters Department of the Army Deputy Chief of Staff-G4 assigned to the Pentagon in Washington, DC. She earned citations for Meritorious Service, and her service includes time stationed in Korea and Iraq.

Why She Served: Alongside people around the globe, Hickman was shaken after the September 11th attacks on U.S. soil, which occurred shortly after she began her undergraduate studies at the University of Memphis.

“I knew I wanted to join the military at some point, my dad had served and I really admired his service to our country” explains the TC doctoral student, who was raised on service bases around the world. “But 9/11 happened and I decided that was the time to do it.”

What She’s Passionate About: “I consider learning a continuous, lifelong process,” says Hickman, who began teaching during her service in South Korea and would go on to teach at West Point as an assistant professor.

Outside of her scholarship and her career, Hickman enjoys spending her time with her college sophomore daughter who is also the Miss District of Columbia Teen USA.

FDA says West Columbia drug maker not done enough to find cause behind 3.8M dose recall

WEST COLUMBIA — A warning letter from the U.S. Food and Drug Administration said a West Columbia drug maker has not gone far enough in its response to concerns raised during an annual inspection that led to the recall of more than 3.8 million doses of generic drugs.The federal agency responsible for regulating pharmaceutical production in the United States...

WEST COLUMBIA — A warning letter from the U.S. Food and Drug Administration said a West Columbia drug maker has not gone far enough in its response to concerns raised during an annual inspection that led to the recall of more than 3.8 million doses of generic drugs.

The federal agency responsible for regulating pharmaceutical production in the United States went on to threaten Nephron Pharmaceuticals with possible “seizure and injunction” if violations were not quickly corrected. The violations could also jeopardize the company’s ability to compete for other federal contracts.

Regulators say the drug maker has fallen short of expectations in its internal investigations to get to the root of the issues behind the recalls.

Nephron said it is taking the FDA’s letter seriously.

“We will continue to work with the FDA in the same collaborative and cooperative way we have this year to resolve any outstanding matters,” the company said in a statement. “Our commitment to quality remains second to none because the lives of patients depend on the hard work of our team.”

Nephron did not specify whether it would need to halt all or part of its production while it gets into compliance. Previously, the company has said it was continuing operations while the FDA conducted its enforcement measures.

In the lengthy letter, FDA officials cited issues with different drugs getting mixed together, causing cross-contamination, during the manufacturing process and rehashed concerns raised in a nearly month-long inspection this spring related process meant to ensure the pharmaceuticals produced are sterile.

Sterility assurance refers to the probability that bacteria, viruses or other microorganisms are unable to survive the sterilization process. Federal regulations require that drug makers demonstrate a certain level of confidence in the sterility of their products.

Since the beginning of the year, Nephron has issued three rounds of recalls impacting 219 lots of drugs, used by health care providers for everything from inducing labor and controlling blood pressure to anesthesia and treating calcium deficiencies.

The majority of the drugs involved in the recalls are part of Nephron’s compounding drug operation, which produces high-demand, commonly-used drugs for hospitals and medical clinics across the country.

An example of the violations cited in the letter included an instance in April 2, 2021, when traces of the drug Bupivacaine, a local anesthetic used to numb an area of your body during surgery, childbirth or dental work, were found mixed in another batch of drugs produced at the facility. Nephron uses the same equipment to make and sterilize different types of drugs. It was also found that equipment used to seal IV bags was flawed.

Nephron opened an internal investigation into the incident, which lasted through the time of the FDA’s inspection nearly a year later. During that year, Nephron had continued with the same manufacturing practices despite the cross-contamination findings.

To correct the problem, Nephron started running the equipment through an extra cycle between batches of different drugs to clean it.

But the FDA said that response was “inadequate” because it did not take into account other ways cross contamination might be taking place, like the quality of materials used to package the drugs. The agency also said Nephron’s studies to ensure new practices were working was not robust enough.

In another example cited in the letter, a bacteria that the U.S. Centers for Disease Control and Prevention says can cause pneumonia and blood infections, was found within equipment in the facility. After cleaning and disinfecting the equipment, Nephron did a single trial run on the machinery rather than the three runs the FDA said is needed.

In its internal investigation of the incident, Nephron said the results had actually been a laboratory error and retrained its lab employees. But the FDA contends the company’s investigation didn’t go far enough to show clear evidence that it had indeed been a laboratory error and not a possible contamination.

When it comes to sterility assurance, the federal standards can be a bit vague industry consultants said.

Exact requirements are not always spelled out in regulations, leaving some things open to interpretation. In Nephron’s case, it was using a lesser standard when it came to monitoring the presence of microorganisms popping up in its clean rooms.

While the federal regulatory code does not expressly set out a specific threshold for when a company should investigate instances of microorganisms in their sterile environments, consultants say enforcement trends by the agency in recent years have pointed to more stringent preferences.

The warning letter makes it clear in the case of Nephron, telling the company it must respond to the agency with how it plans to ensure investigations are appropriately conducted.

The FDA, in its letter, has suggested Nephron hire a consultant to perform a comprehensive audit of the company’s entire operation to ensure compliance and corrective actions.

Such a vast revamping of procedures can be disruptive and require the attention of numerous employees. This can often lead to a facility pausing operations and shortages of the drugs they produce.

Only one drug produced by Nephron appears on the federal drug shortage list — Disopyramide Phosphate, used to treat irregular heartbeat.

Nephron has the capacity to produce more than 1 billion doses of various pharmaceuticals annually, the company said. In its compounding operations, the company is approved to make some 125 types of sterile drugs, CEO Lou Kennedy previously told The Post and Courier.

Neohron has been on a growth wave in recent years, building out its sprawling campus to add production of at-home COVID-19 test kits and medical gloves, a new 110,000-square-foot wing where it will begin making chemotherapy drugs and a number of antibiotics, a new 200,000-square-foot warehouse where it plans to fill vaccines, and a new subsidiary that will make a portion of the medical devices and packaging that Nephron previously contracted out.

This is in addition to the respiratory medications the company has long been known for.

The company employs roughly 1,200 full-time and 3,000 part-time workers.

US Food And Drug Administration Descends Upon Nephron Pharmaceuticals

Less than a week after we reported on a blistering rebuke Nephron Pharmaceuticals received from the U.S. Food and Drug Administration (FDA), the South Carolina-based crony capitalist drug manufacturer was paid yet another visit by the federal agency.According to multiple sources familiar with the situation, eight FDA inspectors arrived at Nephron’s West Columbia, S.C. hea...

Less than a week after we reported on a blistering rebuke Nephron Pharmaceuticals received from the U.S. Food and Drug Administration (FDA), the South Carolina-based crony capitalist drug manufacturer was paid yet another visit by the federal agency.

According to multiple sources familiar with the situation, eight FDA inspectors arrived at Nephron’s West Columbia, S.C. headquarters on Tuesday afternoon (November 8, 2022) for the purpose of conducting ongoing monitoring of the results-challenged facility.

The inspectors are expected to stay on site “through the weekend or longer.”

“They are watching procedures from start to finish,” a source familiar with the situation told me.

Federal agents also paid a visit to a Nephron facility in Murray, Kentucky, sources said.

DON’T MISS A STORY …

The inspectors who visited the West Columbia facility were on-site until approximately 6:15 p.m. EST on Tuesday evening. After they departed, Nephron chief executive officer Lou Kennedy held what our sources have described as a “tense” closed door meeting with multiple department heads.

As I reported last week, FDA officials sent a letter to Kennedy on October 21 alerting her to “serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.”

“It appears you produced drugs that violate the FDCA,” the letter noted, a reference to the federal Food, Drug, and Cosmetic Act (FDCA).

The FDA also accused Nephron of failure to take “appropriate corrective actions” in response to prior inquiries and failure to “perform adequate product evaluation after approximately 1,686 excursions of microbial contamination were recovered” from a processing area.

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“There is a lack of assurance that your firm can aseptically produce drug products within your facility,” the warning letter asserted.

My news outlet previously reported on an FDA investigation of Nephron back in May – an inquiry which “focused on its (supposedly) sterile compounding center” in West Columbia. A week later, the company recalled four lots of drugs due to a “lack of assurance of sterility.”

That recall impacted more than two million doses of multiple drugs.

Nephron has repeatedly found itself in hot water with federal authorities in recent years. In September of 2020, the company was accused of running afoul of the Federal Trade Commission (FTC) after falsely advertising its products as having been “Made in the USA.”

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(Via: Facebook)

Prior to that, Nephron was slapped with a warning from the FDA after touting one of its drugs as a “cost-effective way to treat” Covid-19 – even though it had not been approved for such use.

As I often point out to my audience, Nephron has benefited richly from taxpayer-funded incentives provided at the behest of former South Carolina governor Nikki Haley and other “Republican” politicians.

In addition to the tens of millions of dollars in taxpayer-funded handouts it has received, Nephron is one of the leading drivers of crony capitalism across South Carolina. Kennedy in particular is a former president and board member of the über-liberal S.C. Chamber of Commerce – the Palmetto State’s staunchest defender of market-distorting taxpayer-funded subsidies.

Nephron’s senior vice-president Rob Godfrey – a former Haley advisor – still serves on the chamber board.

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My news outlet has consistently opposed such crony capitalist subsidies, arguing they force taxpayers to shell out for jobs that don’t always come – or come at a price that isn’t worth the investment. More fundamentally, it isn’t government’s job to invest in the private sector.

“Subsidies like this are pure theft – taking money from individual taxpayers and small businesses lacking in political clout and transferring it to corporations that have it,” I wrote four years ago. “Sure, jobs are often created as a result of these subsidies, but no one ever bothers to count the jobs that are lost – or the economic activity that doesn’t take place because all of that money got vacuumed out of the consumer economy.”

Don’t believe me? Look at what just happened with the Carolina Panthers

Instead of continuing with their failed approach of picking winners and losers in the marketplace, policymakers ought to pursue specific economic policies which place a premium on small business growth, entrepreneurship and expanded economic equality for all taxpayers.

(Via: FITSNews)

Will Folks is the founding editor of the news outlet you are currently reading. Prior to founding FITSNews, he served as press secretary to the governor of South Carolina. He lives in the Midlands region of the state with his wife and seven children. And yes, he has lots of hats – including that Indianapolis Colts’ greyscale lid pictured above.

Got something you’d like to say in response to one of our articles? Or an issue you’d like to address proactively? We have an open microphone policy here at FITSNews! Submit your letter to the editor (or guest column) via email HERE. Got a tip for a story? CLICK HERE. Got a technical question or a glitch to report? CLICK HERE.

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We Z-evoured the Z-eriously Great Burgers at Zesto in West Columbia, SC, Along With a Creamy Butterscotch Milkshake

West Columbia, SCDriving the interstate from Atlanta to Myrtle Beach near lunchtime in Columbia, SC, we were faced with the usual assortment of exit-centric fast foods, all trying to compete for our passing attention with road sign advertising. But on early-fall Saturday day, we had a little extra time and decided to venture off the raceway to find something with more character.And that's how we discovered Zesto of West Columbia, f...

West Columbia, SC

Driving the interstate from Atlanta to Myrtle Beach near lunchtime in Columbia, SC, we were faced with the usual assortment of exit-centric fast foods, all trying to compete for our passing attention with road sign advertising. But on early-fall Saturday day, we had a little extra time and decided to venture off the raceway to find something with more character.

And that's how we discovered Zesto of West Columbia, following a winding GPS routing that led us off the most-beaten path and into the land of drive-in chicken, burger and shake greatness.

If you don't know the Zesto story, it's the reverse of the usual chain restaurant. Zesto was founded after World War 2 by a company which made "Zest-0-Mat" frozen custard machines. Dozens were opened throughout the South and Midwest. Then the parent company changed approaches, dropped the concept, and left the owners to fend for themselves, independently.

The West Columbia location has been around since 1949, according to the website. We're not sure, but based on the crazy and carved-up layout of the building, we'd guess the business grew from a window service ice cream shop featuring soft-serve to include the addition of multiple dine-in areas.

The promise of good burgers, fries and a shake drew us here, and Zesto delivered on and exceeded all our expectations. And while I could go on and on about the experience at Zesto, that wouldn't do justice to the simple goodness at the core of the menu.

Our meals: Fresh cooked, juicy hamburgers and cheeseburgers, dressed to order and wrapped in white paper. Crispy battered moist and juicy fried chicken. Fresh cooked and piping hot thick fries. A chocolate dipped vanilla cone. A thick chocolate milkshake. And the piece-de-resistance: a scrumptious butterscotch shake -- large, of course, because this much flavor must be enjoyed in mass quantities!

If you're getting the impression that Zesto made us simultaneously nostalgic about old-fashioned burger joints and thankful for modern Yelp! and Google ratings, you'd be 100% correct. In fact, we may just have to schedule a college visit for our graduating senior to nearby USC just to have an excuse to drive the 243 miles from our Georgia home to visit again.

You'll find Zesto of West Columbia at Zesto of West Columbia, 504 12th St, West Columbia, SC 29169.

I'm a Georgia based family excursion, outdoors and travel blogger. You can follow my blog at: OurTravelCafe.com. You can also follow me here on Newsbreak. Simply use the "follow" button, located before and after this article on your phone, or on the left side menu on your computer.

And see these recent Southeast region posts by DeanLand on Newsbreak and OurTravelCafe.com:

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