FDA 483 - Chemolee Lab Corporation - May 30, 2025

An FDA inspection of Chemolee Lab Corporation in Irving, TX, from May 19-30, 2025, revealed extensive deficiencies across its quality systems. The firm failed to establish an adequate Quality Unit, conduct proper annual product reviews, perform sufficient product testing and process validation, and maintain appropriate data integrity controls. These issues collectively indicate a severe lack of control over the manufacturing processes for their OTC drug products, compromising product quality and safety.