FDA report into SC’s Nephron raised concerns ahead of drug recall
Records from an inspection of Nephron Pharmaceuticals’ Lexington County compounding facility raise issues similar to those that led to the recall of millions of Nephron-produced drugs last month.
A report by inspectors from the Food and Drug Administration raised concerns about Nephron’s process for ensuring the sterility of its products — and thus make sure its drugs are safe for customers to consume. The report also raises questions about the company’s internal process for monitoring and investigating issues that arise at the facility, located south of Cayce.
Nephron, a major employer in the Columbia area, has voluntarily recalled millions of pharmaceutical products, saying it couldn’t ensure the products were sterile.
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.
The FDA report follows an inspection at the Lexington County site between March 28 and April 20, according to the report.
Nephron is in the process of updating its procedures, the company told The State. Those changes could led to changes or pauses in Nephron’s production schedules.
“As always, after an inspection by the agency, Nephron is proactively cooperating with the FDA to address any feedback the company received, or issues that arose, and this time is no different,” Nephron CEO Lou Kennedy said in a statement.
Federal inspectors criticized the number of “excursions” by outside organisms found in Nephron’s processing facilities, where high levels of cleanliness are necessary. The agency noted more than 1,600 such incidents were recorded in 2021 and the first quarter of 2022.
“Your firm has not conducted investigations into the majority of environmental monitoring and personnel monitoring excursions (recovery of organisms)“ the report reads. “Your firm stated that approximately 240 excursions were related to monitoring of personnel who performed filling/capping and sanitizer functions, which are critical roles during the aseptic filling of sterile drug products, were not investigated.”
Of 51 recorded excursions in one sterile environment, the FDA says no investigation was done into 48 of them.
In one instance, samples from personnel and surfaces in an area where pharmaceutical products were filled showed the presence of penicillium guizhouanum. Penicillium is a culprit behind many household molds. “No investigation was performed for the media fill excursion and the disposition was ‘pass,’” the report notes.
Many of the items recalled by Nephron in May were pre-filled syringes of various drugs.
The report also said many such incidents in microbiology labs “are not thoroughly investigated before invalidating results and concluding no microbial contamination,” and that existing procedures did not adequately validate a sterile environment.
“The personnel looking at the media filled syringes were inconsistent with their process of reading them,” the report says. “We observed one inspector to initially stand during the reading holding the vial about the light source and then later sit. We also observed both primary inspectors to sometimes shake or invert quickly the syringe before initially looking at the syringe which may make it difficult to detect slight or low levels of contamination.”
Nephron employs 4,000 full- and part-time employees at a 715,000-square-foot campus in a Lexington County industrial park south of Cayce, which opened in 2015.
This story was originally published June 6, 2022 at 1:44 PM with the headline "FDA report into SC’s Nephron raised concerns ahead of drug recall."
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