FDA 483 - Ames Goldsmith Corporation - March 06, 2020

Ames Goldsmith Corporation, an Active Pharmaceutical Ingredient (API) manufacturer in Glens Falls, NY, was cited for multiple repeat observations during an FDA inspection. The inspection revealed significant deficiencies in quality control, including inadequate investigations into batch discrepancies, lack of validated manufacturing processes and equipment, and insufficient stability studies for Silver Nitrate USP. These issues indicate a systemic failure to adhere to good manufacturing practices.