Incell warned for marketing unapproved product, CGMP violations

The US Food and Drug Administration (FDA) has issued a warning letter to Incell Corporation for selling amniotic fluid-derived products without approval and failing to meet the agency’s current good manufacturing (CGMP) requirements. Inspectors said they found several problems with how the company marketed, labeled, and manufactured their products.

In its 12 December letter, FDA cited the San Antionio, TX-based firm for selling biological products derived from amniotic fluids without FDA approval. The agency noted that the company states, among other places, on its website that its biological product is intended for diagnosing, curing, mitigating, treating, or preventing disease or conditions, but the product has not gone through agency review.

“Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid biologics license application (BLA) must be in effect,” said FDA. “Such licenses are issued only after showing that the products are safe, pure, and potent. Your product is not the subject of an approved BLA.”

FDA noted several CGMP violations during a September 2023 inspection at its San Antonio manufacturing facility, including failing to establish and follow written procedures to prevent microbiological contaminations, establishing laboratory controls to ensure the final product conforms to proper standards, and establishing a written testing program for product stability testing. The company was also cited for misbranding its product because its labeling was found to be false or misleading.

FDA inspectors noted that in 2020, Incell produced another product derived from amniotic fluid and asked for clarification on whether it is still making the product or plans to resume its manufacture.

Finally, FDA raised concerns that Incell did not provide evidence that it conducts adequate environmental monitoring. The agency said that batch record results show only passive microorganism monitoring and non-viable particulate monitoring.

“There is no mention of viable microorganism monitoring such as [redacted] sampling and personnel monitoring in association with each batch,” said the agency. “Various sampling methods are needed to adequately identify potential routes of contamination.”

Incell was given 15 working days to respond to FDA’s warning letter.

Warning letter

Incell warned for marketing unapproved product, CGMP violations

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