FDA 483 - Chartwell Pharmaceuticals West Caldwell LLC - December 18, 2024

An FDA inspection of Chartwell Pharmaceuticals West Caldwell LLC's control testing laboratory in West Caldwell, NJ, revealed significant deficiencies in their quality control processes. Observations included failures to establish proper performance qualification studies for HPLC systems and validate associated computer software, as well as not performing routine equipment inspections according to a written program. Additionally, the firm failed to assess equipment and software validations from previous occupants and used laboratory equipment to test drug products past their calibration due dates.