FDA 483 - Pfizer Healthcare India Private Limited - September 02, 2019

An FDA inspection of Pfizer Healthcare India Private Limited in Visakhapatnam identified critical deficiencies in their sterile drug product manufacturing. The firm failed to thoroughly investigate sterility test failures and environmental monitoring excursions, indicating a lack of robust root cause analysis. Additionally, the quality unit did not adequately manage sterilization alarms or ensure proper biological quality laboratory operations, and disinfectant validation was found to be insufficient against prevalent microorganisms.