FDA 483 - Sanitor Corporation - April 14, 2023

Sanitor Corporation, a contract drug manufacturer in Stanton, CA, was cited for five significant deficiencies during an FDA inspection. The observations highlight systemic issues including inadequate quality control unit procedures, compromised data integrity due to poor computer system controls and backup processes, and widespread failures in employee cGMP training. Additionally, the firm failed to establish appropriate storage conditions based on stability testing and maintained inadequate environmental controls for drug products and raw materials.