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# 3 Observations in Sun Inspection
- URL: https://www.fdaweb.com/3-observations-in-sun-inspection/
- Published: 2018-03-06T12:00:00.000Z
- Updated: 2026-09-14T23:27:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140915

FDA released 3/7 the FDA-483 issued following a 2/12-2/23 inspection at Sun Pharmaceutical Industries, Gujarat, India. Specific observations shown on the form [were](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM599549.pdf?ref=fdaweb.com): 

- separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products;
- · written procedures for cleaning and maintenance fail to include description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance; and
- written procedures describing in sufficient detail the sampling, testing, approval, and rejection of drug product containers and closures are lacking.