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

An FDA inspection conducted at Denison Pharmaceuticals, LLC from January 5 to February 9, 2023, identified significant deviations from Current Good Manufacturing Practices (CGMP) for human drug manufacturing. Key findings included a systematic failure to thoroughly investigate product quality issues, such as microbial contamination, adverse events, and container leakage, often despite documented evidence of problems. The firm also failed to perform critical identity testing for raw materials like Glycerin USP and Propylene Glycol USP, potentially introducing contaminants into products for children and infants. Microbiological testing methods were unvalidated, yielding unreliable results, and contaminated water sources were used in production. Manufacturing processes for certain drug products, like Safe Tussin PM, lacked validation, leading to assay and yield inconsistencies. Furthermore, the company's quality control unit exhibited substantial delays in completing investigations and corrective actions. Poor employee sanitation practices, unvalidated equipment cleaning systems, and the presence of damaged manufacturing equipment in clean areas also contributed to the non-compliance. Denison Pharmaceuticals is required to promptly address these serious deficiencies to ensure the quality, safety, and regulatory compliance of its drug products.