FDA report shows issues at West Columbia pharmaceutical company under recall

WEST COLUMBIA, S.C. (WIS) - An FDA report shows issues at the Nephron facility in West Columbia that is under a recall of over 2.1 million doses of medicine.

In the report obtained by WIS, inspectors from the organization made seven observations during inspections at the building, located in the 4500 block of East 12th St.

The inspections happened between March, 28, 2022 and April 20, 2022.

Observation 1

“There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications where or not the batch has been already distributed.”

Observation 2

“Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.”

Observation 3

“Test procedures relative to appropriate laboratory testing for sterility are not written and followed.”

Observation 4

“Procedures designed to prevent microbial contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.”

Observation 5

“All records of production and control associated with a batch of drug product were not maintained

(b) (4) after the expiration date.”

Observation 6

“Laboratory records are deficient in that they do not include the initials and signature of the person reviewing the record for accuracy.”

Observation 7

“Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 503B because they (a) are not used to compound drug products that appear on the drug shortage list in effect under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk drug substances for which there is a clinical need. Specifically, your firm compounds glycopyrrolate.”

We have embedded the full report below.

When WIS reached out to Nephron earlier this week about the recall they provided these statements,

“Out of an abundance of caution, Nephron is proactively cooperating with the Food and Drug Administration on a voluntary recall of a limited number of product lots. We do not take this lightly. While there has been no impact to patient safety, and there is no evidence of contamination, Nephron has decided in the interest of patients to proceed with this recall process. The company is prepared to provide the resources and information necessary to health care providers and patients to make certain they have anything they need and any questions answered. They remain our top priority,” said Lou Kennedy, Nephron Pharmaceuticals Corporation CEO & Owner.

The company wrote in response to a request for clarification if they’d been recently shut down,

“The 503B compounding operation is open. As part of the continuing process to complete a recent and routine FDA inspection, and ensure Nephron has provided the agency with everything they need in response, there have been ongoing updates to processes around the facility. Some of these ongoing updates may result in changes or pauses to production schedules or outbound packaging in 503B. The company is in constant contact with hospitals and customers with any questions.

Nephron proudly produces more than 1B doses of life-saving medication each year across the across the company, and will continue to do so, because patients count on it for a variety of conditions. With respect to the product lots impacted by the voluntary recall, in which there has been no danger to patient safety, and no contamination, the company will continue to work proactively with the Food and Drug Administration until this process is completed.”

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