FDA 483 - Generitech Corporation - July 28, 2021

An FDA inspection of Generitech Corporation, an Over the Counter Drug Manufacturer in Fresno, CA, revealed significant deficiencies across multiple systems. The firm failed to thoroughly investigate out-of-specification results, lacked validated test methods and process validation, and exhibited poor control over raw material testing and stability programs. Additionally, issues were noted in batch record completeness, equipment cleaning validation, and overall quality unit responsibilities.