FDA 483 - Master Paints & Chemical Corp - October 17, 2023

An FDA inspection of Master Paints & Chemical Corp in Guayanilla, PR, a drug product manufacturer, revealed significant deficiencies across multiple areas of its operations. The firm failed to reject out-of-specification drug products, lacked adequate testing procedures and instrument calibration, and did not validate manufacturing processes or provide GMP training to employees. These issues indicate a systemic failure to adhere to good manufacturing practices, potentially compromising drug product quality and safety.