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# CGMP Violations in Sun Pharmaceutical Inspection
- URL: https://www.fdaweb.com/cgmp-violations-in-sun-pharmaceutical-inspection/
- Published: 2024-07-08T12:00:00.000Z
- Updated: 2026-09-14T14:34:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157287

A 12/4-12/15/2023 FDA inspection at the Sun Pharmaceutical Industries Limited drug manufacturing facility in Union Territory Dadra and Nagar Haveli and Daman and Diu in India found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/18 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024?ref=fdaweb.com) says the specific violations were:

- failure to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements; and
- failure 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 has already been distributed.

The letter says the inspection observations also were found in 2017 and 2019 and were found at multiple company sites. “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate,” the letter says…. “Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP…. We strongly recommend that your firm engage a consultant … to assist your firm in meeting CGMP requirements.”

Sun was told to promptly correct the violations and to respond with a list of specific actions it has taken to address any violations and prevent their recurrence, with a schedule for completing the corrections.