FDA 483 - Denison Pharmaceuticals, LLC - February 09, 2023

Denison Pharmaceuticals, LLC received a Form 483 citing nine observations related to significant quality control and manufacturing deficiencies. The firm failed to thoroughly investigate numerous product quality complaints, adverse events, and out-of-specification results, including microbial contamination and container closure integrity issues. Additionally, the inspection revealed inadequate validation of test methods and manufacturing processes, poor sanitation practices, and a failure to complete corrective and preventive actions within established timeframes.