Years after warning from FDA, Nephron sees ‘egregious’ violations in inspection
Despite multiple warnings from the Food and Drug Administration about its manufacturing processes, Nephron Pharmaceuticals, one of the largest employers in Lexington, has continued to face federal regulatory scrutiny, its most recent inspection report showed.
The report revealed the company still doesn’t have the systems in place to ensure its products are made in a sterile environment and that the company has failed to properly address issues with sterility issues. Some issues — like a lack of proper investigation into reported issues with the company’s drugs and insufficient procedures for monitoring how products are made — have plagued the company for years, records showed.
“If you don’t even have an operating procedure that employees have to follow, then you’re really shooting in the dark. You’re leaving it to happenstance,” said Carol Beirne, the faculty director at Northwestern University’s graduate program for regulatory compliance.
“If [a company] doesn’t even have a procedure, I can tell you, that’s very egregious,” Beirne, previously a corporate quality manager at Abbott Laboratories, told The State.
The FDA’s report comes nearly three years after Nephron received two separate warning letters from the regulatory agency. Warning letters are formal notifications from the agency that the company is violating federal laws. The company voluntarily recalled more than 2 million drug doses over concerns about sterility in 2022. Some of the same issues from 2022 still persist.
The report comes at the same time that the building Nephron uses as its headquarters has been listed for sale at $340 million. The company has said it intends to lease back the building once it is sold.
What did the FDA find?
Inspectors with the FDA — which is responsible for, among other things, regulating food, drugs, tobacco products and cosmetics — visited Nephron’s facility at 4500 12th St. Ext. in Lexington County 10 times between Aug. 11 and Aug. 22, 2025, according to inspection documents. The agency noted six observations:
- Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.
- Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
- Failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
- Failure to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
- Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
- The responsibilities and procedures applicable to the quality control unit are not fully followed.
At least four of the inspectors’ observations were ones that had been noted as issues in previous reports in 2023 and 2024. The company has repeatedly been cited by the FDA for a lack of written procedures, staff’s inability to follow regulatory protocols and failure to properly investigate and address problems.
In February 2024, the company identified an issue with a portion of its environmental monitoring, a federal requirement that pharmaceutical manufacturers must follow in order to monitor and record any instances of contamination. A year later, Nephron closed out a corrective action plan without determining the cause of the issue, federal regulators said in their most recent report. That comes more than a year after two separate complaints were filed with federal regulators about Nephron’s products.
Nephron employees routinely failed to follow protocols meant to keep drugs sterile, federal regulators found. An alarm meant to alert employees to changes in pressure had been sounding all morning when the FDA conducted a walkthrough of the facility in August.
“I don’t do anything about alarms,” an employee told federal regulators, according to the report. The company’s chief quality officer told inspectors that employees are trained to report and escalate alarms, but no investigation was initiated until regulators inquired.
The lack of management and oversight created an “unacceptable risk of microbial ingress and contamination of sterile products,” the report said. Regulators said it “undermines sterility assurance and patient safety.”
Despite this, the company’s website posits that its “team of experts ensure every substance that enters and exits our facility is safe for use.”
In another instance, regulators noted that the company had “failed to exercise appropriate controls ... to assure that only authorized personnel institute changes in master production and control records.” Nephron’s chief technology officer presented regulators with a file that contained “approximately 18,022 logged ‘Access Violation’ errors” from April 2024 to March 2025, but neither the company’s management nor its technology vendors could explain the cause or impact of those errors.
What does this mean for Nephron?
The inspection report comes three years after the company received a third warning letter from the FDA — one in 2020 for false and misleading drug marketing and two in 2022 for a host of other issues. For the two letters from 2022, the FDA has not issued close-out letters — standard protocol when a company has addressed problems noted in the agency’s warning letter — according to the FDA’s website. An FDA spokesperson confirmed to The State that “compliance activities for this firm are ongoing.”
Of the 1,210 warning letters sent to companies in South Carolina since 2020, only 11 were for drug products. The majority of warning letters are sent to companies selling or producing tobacco products. Of those 11 instances of drug products receiving warning letters in South Carolina, Nephron represented three.
Following inspections, the FDA usually dictates what issues there are and gives companies the opportunity to correct them, Beirne explained.
“If this is already a repeat observation, they’re probably not going to go that route. They have the right to shut the organization down,” Beirne said.
She added that the federal agency can go beyond a warning letter and issue what’s known as a consent decree, which would take all or a portion of the company’s product off the market. If that happened, the company would have to meet a more rigorous standard of addressing its issues before being allowed to sell its products again.
It’s unclear what, if any, next step the agency will take. The FDA generally does not discuss compliance matters except with the company involved, a spokesperson for the agency told The State. Given the company’s ongoing compliance measures, Beirne said she’d be surprised if Nephron was still manufacturing products dinged during its inspection.
When reached by a reporter with The State, the company’s CEO, Lou Kennedy, declined to answer questions. It’s unclear which products, if any, the company is still manufacturing.
History of repeated issues
Nephron has been flagged for some of the same issues — namely, procedures meant to keep drugs sterile not being written or followed and inadequate environmental monitoring — since at least 2019, prior inspection reports showed. It’s issued 20 recalls for its products since 2012, according to data from the FDA.
The issues have led to at least two instances of problems with drugs that were distributed by the company, according to complaints filed with the FDA. One complaint, in February 2024, came from a parent whose child’s medication had a fruity odor and another in March 2024 from a hospital pharmacy director complaining about dark particles in a vial of medication typically used for asthma.
After receiving the complaints, Nephron failed to review the unexplained discrepancies, inspectors said in a 2024 report. It wasn’t the first time the company had failed to address known sterility issues.
A 2021 investigation done by the company found cross contamination in at least three lots of drug products, but did not “adequately identify the root cause or scope of potentially impacted lots in a timely manner,” according to an FDA warning letter from Oct. 2022. The FDA also criticized Nephron for its delay in alerting regulators to issues with a drug it’d already distributed.
“Only after the FDA’s inspection did you perform additional investigation,” the agency wrote. “Your lack of timely and comprehensive investigation failed to identify the extent of the cross-contamination hazard to marketed drug products.”
This story was originally published October 22, 2025 at 5:00 AM.
