FDA 483 - Chemco Corporation - August 22, 2025

Chemco Corporation in Miami Lakes, FL, a manufacturer of cosmetics and OTC drugs, received a Form 483 with eight observations during an FDA inspection. The inspection revealed significant deficiencies across multiple areas, including inadequate process and cleaning validations, insufficient incoming material testing, lack of proper laboratory controls for impurity testing, and failures in OOS investigations and data integrity. Additionally, the firm lacked appropriate controls for retain samples and timely annual product reviews, indicating a broad lack of adherence to GMP requirements.