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# Scathing FDA-483 Hits Sun Pharma Over GMPs
- URL: https://www.fdaweb.com/scathing-fda-483-hits-sun-pharma-over-gmps/
- Published: 2022-05-13T12:00:00.000Z
- Updated: 2026-09-14T17:44:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151812

A scathing 23-page Form FDA-483 cites 10 GMP deficiencies at Sun Pharmaceutical Industries’ Halol manufacturing facility (Gujarat, India). The company announced earlier in the week that the inspectional observation form was issued 5/9 at the conclusion of its inspection, and the agency has now released the [redacted form](https://www.fda.gov/media/158415/download?ref=fdaweb.com) under the Freedom of Information Act.  

The Halol facility has a long history of FDA trouble, but over the past few years it appeared as though the company had resolved most significant issues, and its last inspection in 2019 resulted in a “no action indicated (NAI)” classification. Currently, the 5/9 inspection has yet to be classified.

According to the FDA-483, Sun was cited for not having procedures that cover the adequate validation of the facility’s aseptic process. It was also cited for its quality unit failing to identify manually intensive operations for environmental sampling. The company also failed to adequately clean, maintain and sanitize equipment. Additionally, it failed to follow the written stability testing program. For example, the form says the quality control lab failed to test more than 200 stability samples within the appropriate timeframe.