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# Agency Cites Dr. Reddy’s Again After Inspection
- URL: https://www.fdaweb.com/agency-cites-dr-reddys-again-after-inspection/
- Published: 2017-02-23T12:00:00.000Z
- Updated: 2026-09-14T22:08:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138053

FDA 2/21 issued Dr. Reddy’s Laboratories a three-observation Form-483 after inspecting its Miryalaguda active pharmaceutical ingredients (API) plant in Telangana, India. The API plant was cited in a 2015 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473604.htm?ref=fdaweb.com), and this presumably was a follow up inspection based on comments made late last year by senior company officials who indicated corrections had been made and they awaited reinspection.

“The audit of our API manufacturing plant at Miryalaguda, by the U.S. FDA, has been completed today (February 21, 2017). We have been issued a Form-483 with three observations, which we are addressing,” Dr. Reddy’s said in a stock exchange filing. The company declined to provide details on the cited observations.

  
The 2015 Warning Letter cited manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, and followed earlier inspections of these sites by the agency in 11/2014, 1/2015, and 2/2015\. The company was sent a [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm258679.htm?ref=fdaweb.com) in 2011 after an API facility in Mexico was inspected. According to that letter, the firm did not validate analytical methods used to test APIs. It also had incomplete cleaning validation for non-dedicated manufacturing equipment, and its out-of-specification investigations did not include analysis of all available data.