> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Cites Sun Pharma Over GMP Violations
- URL: https://www.fdaweb.com/fda-cites-sun-pharma-over-gmp-violations/
- Published: 2022-08-19T12:00:00.000Z
- Updated: 2026-09-14T17:56:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152550

A just-completed FDA inspection of Sun Pharmaceutical Industries’ Punjab, India manufacturing facility resulted in a six-item [Form FDA-483](https://www.fda.gov/media/161042/download?ref=fdaweb.com). The form cited Sub for failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Specifically, the agency said a company investigation into alleged backdating by quality assurance and quality control personnel confirmed this was occurring, but it was not thorough enough to evaluate the scope of records being backdated.

FDA also cited the firm over its established sampling plans, test procedures and laboratory control mechanisms, which the agency said are not being documented at the time they are performed. Additionally, the agency took issue with the company’s written procedures, which it said are not drafted, reviewed and approved by the appropriate organizational units or reviewed and approved by the quality control unit.