FDA 483 - Chartwell Pharmaceuticals LLC - December 19, 2024

An FDA inspection of Chartwell Pharmaceuticals LLC in Congers, NY, revealed significant deficiencies in manufacturing and quality control. The firm failed to validate numerous manufacturing and packaging processes, lacked proper equipment qualification and cleaning validation, and exhibited issues with cross-contamination control and master batch records. These findings indicate a systemic lack of adherence to good manufacturing practices.