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# Sun Cited in 5-page 483 After Recent India Inspection
- URL: https://www.fdaweb.com/sun-cited-in-5-page-483-after-recent-india-inspection/
- Published: 2019-06-24T12:00:00.000Z
- Updated: 2026-09-15T01:34:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144406

FDA issued a five-page [Form 483](https://www.fda.gov/media/128179/download?ref=fdaweb.com) after it inspected a Sun Pharmaceutical Industries Gujarat, India manufacturing facility 6/3-11\. 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.