Agropharma Laboratories, Inc. – FDA Warning Letter, Nov 3, 2021

The FDA inspected Agropharma Laboratories, Inc. from October 21 to November 3, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The company manufactures over-the-counter antiseptics and hand sanitizers.

Key violations include: 1. **Inadequate Quality Control Unit (QCU):** The QCU failed to ensure drug products comply with CGMP and meet specifications (21 CFR 211.22). The QCU did not provide adequate oversight. 2. **Poor Facility Maintenance:** Drug manufacturing areas were in disrepair, with broken walls, filth, and pooling water near open equipment (21 CFR 211.56(a)). 3. **Lack of Production and Process Control Procedures:** The firm failed to establish written procedures to assure drug product identity, strength, quality, and purity (21 CFR 211.100(a)). Process validation was not established, and the water system used for drug components was not adequately designed, controlled, maintained, or monitored.

The company's December 6, 2021, response to the FDA 483 was deemed insufficient, lacking specific corrective action evidence. The FDA acknowledged the firm's commitment to cease drug production but noted its continued registration as a manufacturer. The FDA strongly recommends engaging a qualified consultant if the firm intends to