FDA 483 - A.I.G Technologies Inc. - May 16, 2025

A.i.g Technologies Inc., a human drug manufacturer, received a Form 483 for multiple deficiencies observed during an inspection. The firm failed to conduct adequate identity testing for raw materials, lacked representative sampling methods, and maintained incomplete laboratory records. Additionally, issues were noted with the qualification and monitoring of the water system and the stability program's container-closure testing.