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# Sun Pharma Gets 10-item FDA-483
- URL: https://www.fdaweb.com/sun-pharma-gets-10-item-fda-483/
- Published: 2022-05-11T12:00:00.000Z
- Updated: 2026-09-14T17:44:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151795

A 5/9-concluded FDA inspection of Sun Pharmaceutical Industries’ Halol manufacturing facility (Gujarat, India) resulted in a 10-item Form FDA-483, according to a company release. Sun says it is preparing a response to the observations, which will be submitted to the agency within 15 business days.

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. According to FDA, the 2019 inspection found no objectionable conditions or the objectionable conditions found did not justify further regulatory action.

The 2019 inspection resulted in a five-page [Form 483](https://www.fda.gov/media/128179/download?ref=fdaweb.com). According to the document, FDA investigators cited the firm for not following procedures that are designed to prevent microbiological contamination of drug products. For example, the form said that the aseptic process validation master plan was not followed during execution of a media fill run. Sun was also cited for not documenting laboratory control mechanisms at the time of performance. For example, the investigators said environmental monitoring of plates showed that in certain instances the primary reviewer performed the plate analysis almost two hours prior to the witness review. And, FDA cited Sun for not validating a process involving air supply, assembly air, and clamp air pressures.

Currently, the 5/9 inspection has yet to be classified and the FDA-483 has not been released.