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# Pfizer Healthcare India CGMP Violation
- URL: https://www.fdaweb.com/pfizer-healthcare-india-cgmp-violation/
- Published: 2020-03-31T12:00:00.000Z
- Updated: 2026-09-14T16:09:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146457

An 8/29-9/6/19 FDA inspection at Pfizer Healthcare India Private Limited, Andhra, Pradesh, India, found a significant violation of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/25 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pfizer-healthcare-india-private-limited-594972-03252020?ref=fdaweb.com) says the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed.

FDA says the company’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. It acknowledges that the company has retained a consultant to audit its operation and assist in meeting agency requirements.

Pfizer was told to submit **(1)** a comprehensive investigation into the extent of the inaccuracies in data records and reporting; **(2)** a current risk assessment of the potential effects of the observed failures on the quality of the company’s drugs, and **(3)** a management strategy for the company that includes details of its global corrective and preventive action plan.

Pfizer also was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.