FDA 483 - Chemtron Biotech, Inc - March 18, 2022

An FDA inspection of Chemtron Biotech, Inc. in San Diego, CA, conducted from March 14-18, 2022, identified a significant issue regarding process validation. The firm failed to adequately validate a manufacturing process, specifically by not performing operational qualification for equipment used in producing in-vitro diagnostic test kits. This lapse indicates a potential risk to the quality and reliability of their finished IVD products.