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Agropharma Laboratories, Inc., a drug manufacturer in Puerto Rico, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter antiseptics and hand sanitizers. The company's quality control unit failed to provide adequate oversight of drug manufacturing and did not ensure proper testing of incoming components for identity, purity, strength, and other quality attributes, resulting in adulterated drug products. The FDA found that despite the company's engagement of a consultant and submission of a response to inspection observations, no specific evidence or corrective actions were provided to address the identified deficiencies.