FDA sends warning to Nephron after Lexington County company’s drug recall

The U.S. Food & Drug Administration sent a warning letter this month to Nephron Pharmaceuticals Corporation, telling the Lexington County company its response to a drug recall was inadequate.

In May, Nephron recalled more than 2 million items produced at its West Columbia compounding center over concerns that the items were not properly sterilized. Many of the items recalled by Nephron in May were pre-filled syringes of various drugs.

The FDA issued a report in June that raised questions about Nephron’s process to ensure its products are safe for customers, in addition to the company’s internal process for monitoring and investigating issues.

The FDA report found “deficient... monitoring (of) environmental conditions” and no “adequate validation of the aseptic process” to determine if there had been microbial contamination of sterile products.

On Oct. 11, in a letter addressed to Nephron CEO and owner Lou Kennedy, the FDA said her company’s response and internal investigation were lacking.

“Your response is inadequate,” the FDA said.

Among the shortcomings, the FDA said Nephron’s investigation relied on limited data and didn’t consider other sources of contamination. There were significant violations of Current Good Manufacturing Practice regulations, according to the FDA.

In an itemized list, the letter says Nephron:

▪ Failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications

▪ Failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile

▪ Failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas

In response to the FDA’s letter, Nephron officials said they are continuing work to resolve the issues.

“First and foremost, we take any such correspondence from the FDA seriously,” Nephron officials said Tuesday in a statement provided to The State. “Second, we will continue to work with the FDA in the same collaborative and cooperative way we have this year to resolve any outstanding matters. Our commitment to quality remains second to none because the lives of patients depend on the hard work of our team.”

In the letter, the FDA said Nephron should get an outside consultant to help the Lexington County company meet the Current Good Manufacturing Practice regulations and audit the company’s entire operation.

“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,” the FDA said in the letter. “Failure to address violations also (can cause the) FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.”

The FDA asked Nephron to respond to the letter in 15 working days to specify what the company has done to address any violations and to prevent them from reoccurring. Nephron officials did not immediately say if the company had yet responded to the FDA’s warning.

Nephron employs 4,000 full- and part-time employees at a 715,000-square-foot campus in an industrial park south of Cayce, which opened in 2015.