FDA 483 - Ames Goldsmith Corporation - May 22, 2025

Ames Goldsmith Corp. in Glens Falls, NY, an API manufacturer, received a Form 483 with six observations related to significant quality system deficiencies. These include unqualified manufacturing and laboratory equipment (a repeat observation), inadequate computer system controls, incomplete analytical data, lack of stability studies, insufficient component testing, and failure to investigate product failures. The findings indicate a broad lack of adherence to good manufacturing practices for Silver Nitrate API.