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FDA report scrutinizes Nephron Pharmaceuticals for production issues

In the 25-page report released this week, inspectors noted several issues.

WEST COLUMBIA, S.C. — U.S. drug regulators issued a report this week detailing issues at Nephron Pharmaceuticals. The inspection was conducted in February at the facility in West Columbia, which supplies inhalation products, gloves, and pre-filled medications to businesses.

In the 25-page report released this week, inspectors noted issues related to cleaning procedures, problems with equipment and maintenance, employees lacking all necessary training and improper storage of ingredients.

Finally, inspectors described a “systemic failure” in how Nephron tracked its inventory.

The West Columbia-based company has faced scrutiny in the past. In October 2022, the FDA issued a warning letter to the company for possible bacterial contamination of equipment and cross-contamination of drugs. 

In January, the U.S. Department of Veterans Affairs (VA) issued an internal recall and removed all products from Nephron Pharmaceuticals.

   

In response to the latest inspection, Nephron CEO Lou Kennedy said in a statement to News 19, in part:

“In the months since the FDA last visited Nephron, we have worked overtime: engaging expert consultants, hiring new talent and addressing any questions inspectors had as a part of the continuous improvement and innovation for which Nephron has come to be known. We look forward to welcoming the FDA back anytime they want to visit and working together to make sure patients have access to the life-saving medications we work hard to produce day in and out.”

The FDA tells News 19 they don’t discuss open compliance matters except with the company involved. there is no evidence that compliance failures flagged in the report resulted in any harm. 

The FDA says that the report contains observations that inspectors deem to be objectionable. 

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