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# FDA Releases Dr. Reddy’s FDA-483
- URL: https://www.fdaweb.com/fda-releases-dr-reddys-fda-483/
- Published: 2019-07-09T12:00:00.000Z
- Updated: 2026-09-15T01:36:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144483

FDA has released the FDA-483 issued following a 6/13-6/21 inspection at the Dr. Reddy’s drug manufacturing facility in Andhra Pradesh, India. Specific inspection observations were: 

- failing to establish acceptance activities prior to performance of validation activities; and
- failing to correctly translate device design into production specifications.