Global Pharma Healthcare Private LimitedMarch 2, 2023

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

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Record Details

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.

Company: Global Pharma Healthcare Private Limited
Inspection Date: March 2, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Rajiv R. Srivastava (Consumer Safety Officer)
Eileen A. Liu

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