13/14 December 2023
Denison Pharmaceuticals LLC, a drug manufacturing company, received a Warning Letter from the U.S. Food and Drug Administration (FDA) on July 26, 2023. The letter summarizes violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
One of the specific violations mentioned in the Warning Letter is the "failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications". For example, Denison Pharmaceuticals failed to perform adequate investigations and expand investigations to all batches and drug products that may have been impacted from contamination by machinery lubricant. The investigation into the contamination of a product with a non-food grade lubricant not intended for ingestion concluded that only one lot was impacted and was rejected. However, the investigation did not consider other potentially affected drug products manufactured in the same mixing tank and indicated that no corrective action and preventive action (CAPA) was required.
The company received multiple odor complaints from customers regarding their products. Also, here, the company failed to adequately investigate these complaints and did not extend the investigation to additional batches. Although microbiological testing failed because of "too numerous to count (TNTC) results for total count of yeast and mold (TCYM)", the lot was seen "fit for use."
The FDA also found that the company's water system had multiple excursions, but the company did not conduct adequate investigations into these excursions. Furthermore, the procedure for sampling and testing of the water system "lacks a mechanism to trigger an investigation in response to severe microbiological excursions from water testing".