FDA has words with South Carolina drug manufacturer Nephron—lots of them

In an exhaustive warning letter earlier this month to Nephron Pharmaceuticals, it took the FDA 4,273 words to break down the problems at the generic drug manufacturer’s plant in South Carolina and issue instructions on how to address them.

Among the problems identified were microbial contamination, cross-contamination, quality control and multiple failures by the company to adequately address problems previously identified by the FDA.

At the end of the expansive account, the regulator essentially said in the letter’s conclusion that the issues were so numerous that they couldn’t all be documented.

“The violations cited in this letter are not intended to be an all-inclusive list,” wrote the FDA.

In addition to threatening Nephron with “seizure and injunction,” the regulator said failure to address violations could “prevent other Federal agencies from awarding contracts.”

The reference is to Nephron’s role as the largest 503(b) outsourcing facility in the U.S. that produces medicines for hospital shortages. That was the status of Nephron in 2020, according to CEO Lou Kennedy, and, as such, the company has cut lucrative deals with the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority. 

During the pandemic, the Nephron’s massive facility just west of Columbia, South Carolina, was churning out 100,000 at-home COVID test kits per day. 

“First and foremost, we take any such correspondence from the FDA seriously," Nephron said in an emailed statement. "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.”

The FDA inspected the facility from March 28 to April 20 of this year. In June, Nephron recalled 2.1 million doses of a variety of medicines because of what the FDA termed a “lack of assurance of sterility.” The recall covered a wide variety of products including sodium bicarbonate injections, ephedrine injections and fentanyl citrate bags.

In the most recent warning letter, the FDA cited Nephron for cross-contamination of at least three lots of drug product and failing to follow up with an adequate investigation into how it happened.

Nephron also was pinged for failing to establish written procedures to prevent microbial contamination of drug products and to establish a system for monitoring environmental conditions in aseptic processing areas.

The FDA gave Nephron 15 working days to respond with its remediation plan. The regulator recommended that the company hire an independent consultant to help it meet CGMP requirements and to have the consultant complete a comprehensive audit of the “entire operation” before pursuing FDA clearance.

Nephron has previously run afoul of the FDA. In 2013, the company was cited for its marketing of an over-the-counter asthma medication. Two years later, the company recalled 80,000 cartons of the drug.

In the same year, Nephron—then with 200 employees and based in Orlando, Florida—established its site in South Carolina. Seven years later, the company's entire operation is in west Columbia and its campus has mushroomed to 715,000 square feet and includes 1,200 full-time and 3,000 part-time workers.