FDA 483 - Global Pharma Healthcare Private Limited - March 02, 2023

An FDA inspection of Global Pharma Healthcare Pvt. Ltd. in Thiruporur, India, revealed significant deficiencies in the manufacturing of sterile drug products. The firm lacked adequate validation for sterilization processes, environmental controls, and equipment, compromising the sterility assurance of products distributed to the U.S. market. Multiple observations highlighted failures in quality control, testing, and adherence to written procedures.