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# Sun Pharmaceutical FDA-483
- URL: https://www.fdaweb.com/sun-pharmaceutical-fda-483/
- Published: 2018-09-27T12:00:00.000Z
- Updated: 2026-09-15T00:34:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142464

FDA has released the FDA-483 with two observations from a 9/10-9/14 inspection at Sun Pharmaceuticals Industries, Punjab, India. The inspection observations were: 

- the quality control unit lacks the responsibility and authority to approve and reject all in-process materials and drug products;
- the written stability testing program is not followed.