FDA 483 - Grato Holdings, Inc. - July 14, 2021

An FDA inspection of Grato Holdings, Inc. in Woodbine, IA, revealed significant deficiencies across multiple areas of their drug manufacturing operations. The firm failed to properly calibrate laboratory equipment, conduct thorough investigations into product discrepancies, and maintain adequate computer system security for analytical data. Additionally, issues were noted with microbiological media testing and the cleaning and sanitization of raw material sampling utensils, indicating a broad lack of adherence to good manufacturing practices.