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# FDA Releases Sun Non-compliance Letter
- URL: https://www.fdaweb.com/fda-releases-sun-non-compliance-letter/
- Published: 2023-05-08T12:00:00.000Z
- Updated: 2026-09-14T18:30:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154394

FDA has posted a “consent decree non-compliance” [letter](https://www.fda.gov/media/167956/download?ref=fdaweb.com) to Sun Pharma outlining inspectional findings at the company’s Mohali (Punjab), India manufacturing facility that led to the agency ordering it to take additional corrective actions to get back into compliance with a 2012 consent decree ([see earlier story](https://www.fdaweb.com/fda-sends-non-compliance-letter-to-sun-pharma/)). Sun Pharma inherited the facility when it acquired Ranbaxy Laboratories in 2015\. In 2013, while Mohali was still part of Ranbaxy, the agency [added](http://fdaweb.com/login.php?sa=v&aid=D5126363&searchWords=mohali&cate=S&stid=%241%24Tn3.go0.%24E8UUahEzP8mkWCCTHn6ng1&ref=fdaweb.com) it to the consent decree with Ranbaxy after two 2012 inspections found significant current good manufacturing practice regulation violations.

FDA’s letter orders Sun Pharma to retain an independent GMP expert to inspect the facility for GMP compliance and to conduct batch certifications of drugs manufactured at the Mohali facility. The expert will also need to submit to FDA for approval a written batch certification protocol applicable to all drugs Sun Pharma manufactures and tests at the facility. “Once FDA has approved the certification protocol, the GMP expert shall immediately begin witnessing the manufacture and testing of all drugs at the Mohali facility intended for distribution to the U.S.,” the letter says.

Additionally, the GMP expert must perform a retrospective review of all drug product batches from the Mohali facility, and the expert must provide a comprehensive report on and a remediation plan for out-of-specification result investigation systems.