FDA 483 - Ultra Chem Labs Corp - July 27, 2022

Ultra Chem Labs Corp in Ontario, CA was inspected by the FDA, revealing significant deficiencies in its manufacturing processes for drug products, particularly Anti-Microbial Alcohol-Free Foaming Hand Sanitizer. The inspection found a complete lack of a quality control unit, inadequate testing of both raw materials and finished products, and an absence of a stability program and proper record-keeping. These issues indicate severe non-compliance with current good manufacturing practices.