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# FDA Releases Sun Pharmaceutical FDA-483
- URL: https://www.fdaweb.com/fda-releases-sun-pharmaceutical-fda-483/
- Published: 2026-01-06T12:00:00.000Z
- Updated: 2026-09-14T15:29:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160428

FDA has released the form FDA-483 issued following a 9/8-9/19/2025 inspection at the Sun Pharmaceutical Medicare sterile drug manufacturing facility in Halol, Gujarat, India. The three specific violations [were](https://www.fda.gov/media/190388/download?ref=fdaweb.com):

- procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, or followed, or include adequate validation of the sterilization process;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions; and
- failure to thoroughly review any unexplained discrepancy, the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been already distributed.