FDA 483 - Spartan Chemical Co Inc - March 26, 2021

Spartan Chemical Co Inc, a pharmaceutical manufacturer in Maumee, OH, was cited for significant deficiencies in its quality control and manufacturing processes during an FDA inspection. The observations highlight critical issues including inadequate water system validation, microbial contamination of hand sanitizers, insufficient laboratory controls, and a systemic failure to investigate discrepancies and manage complaints effectively. These issues indicate a severe lack of adherence to cGMP regulations, posing potential risks to product quality and patient safety.