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# Sun Pharmaceutical 3-Page Form 483 for India Plant
- URL: https://www.fdaweb.com/sun-pharmaceutical-3-page-form-483-for-india-plant/
- Published: 2019-03-25T12:00:00.000Z
- Updated: 2026-09-15T01:15:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143694

FDA has issued Sun Pharmaceutical (Gujarat, India) a [three-page Form 483](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM634208.pdf?ref=fdaweb.com) after a February inspection cited GMP deviations for finished pharmaceuticals. For example, the inspection form says Sun failed to thoroughly review any unexplained discrepancy and 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. The form says the company invalidated out-of-specification results obtained during re-dispersibility tests by attributing them to human error. Investors wrote that root causes were attributed to human error during sample preparation without substantiating with adequate evidence. The company subsequently reported retested passing results.