FDA 483 - Chartwell Pharmaceuticals LLC - December 19, 2024

During an inspection conducted from December 9-19, 2024, the FDA issued a Form 483 to Chartwell Pharmaceuticals LLC, a drug manufacturer located in Congers, NY. The inspection revealed significant deficiencies in the firm's adherence to regulatory standards, indicating a lack of comprehensive controls over drug product quality and manufacturing processes. Key observations included the failure to establish written procedures for production and process controls, specifically, the absence of manufacturing process validation for numerous commercial drug products (e.g., Ondansetron ODT, Ramipril, Griseofulvin, Disulfiram) and insufficient scientific justification for single-batch validations. Packaging process validation was also not performed for several products, notably Folic Acid Tablets and Fluconazole Tablets; this was a repeat observation. Furthermore, non-penicillin drug products were not tested for penicillin cross-contamination when a risk existed, and there was no ongoing monitoring for beta-lactam residue. The FDA also observed that Performance Qualification (PQ) studies for critical drug manufacturing and packaging equipment were incomplete, which was also a repeat observation. Cleaning validation studies for non-dedicated manufacturing equipment were not completed, and cleaning procedures for shared equipment lacked essential details like minimum rinse times and temperatures. Lastly, master production records were deficient, failing to include precise weight specifications per dosage unit and allowing multiple batch sizes for single formulations. Chartwell Pharmaceuticals is required to promptly address these findings to ensure compliance with the Federal Food, Drug and Cosmetic Act and maintain proper Good Manufacturing Practices.