Pfizer Healthcare India Private Limited – FDA 483, Sep 21, 2018

An FDA inspection of Pfizer Healthcare India Private Limited revealed serious data integrity issues within its microbiology laboratory, including supervisors instructing analysts to intentionally falsify growth promotion test results and environmental monitoring data. The firm also failed to submit Field Alert Reports in a timely manner and lacked adequate controls over computer systems to prevent unauthorized deletion of critical data. These findings indicate a systemic breakdown in quality control and data reliability.