FDA 483 - Milbar Laboratories, Inc. - November 07, 2024

Milbar Laboratories, Inc. was issued an FDA Form 483 following an inspection conducted from October 9 to November 7, 2024, citing seven significant observations. The issues primarily concern the company's adherence to Good Manufacturing Practices (GMP) for over-the-counter (OTC) drug products. Key violations include a lack of adequate stability testing data to support expiration dates for several sunscreen products, and a failure to follow the firm's established stability testing program. Equipment maintenance was also deficient, with observations of leaks from a manufacturing vessel's hydraulic lift, without sufficient controls to manage potential product contamination risk. The inspection revealed inadequate environmental controls, specifically a lack of temperature monitoring in both the warehouse, storing finished products and active pharmaceutical ingredients, and the retain sample room. Additionally, the company failed to establish the reliability of component supplier analyses for active pharmaceutical ingredients and showed deficiencies in the design qualification of its purified water system. Finally, the quality control unit lacked proper oversight of third-party laboratory test methods, unable to ensure their appropriateness or obtain necessary documentation. Milbar Laboratories, Inc. is required to address these findings through a robust corrective and preventive action plan to ensure product quality and safety.