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# Dr. Reddy’s India API Facility Hit with 483
- URL: https://www.fdaweb.com/dr-reddys-india-api-facility-hit-with-483/
- Published: 2020-04-03T12:00:00.000Z
- Updated: 2026-09-14T16:09:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146490

FDA has posted a 3/5 [FDA 483](https://www.fda.gov/media/136641/download?ref=fdaweb.com) citing a Dr. Reddy’s Laboratories inspection at a Telangana, India active pharmaceutical ingredient (API) facility conducted 3/1 to 3/5\. According to the 483, FDA found the facility’s system for reprocessing APIs and API intermediates to be insufficient. For example, the agency says that the company does not adequately identify reprocessed batches with a unique material number. It also does not adequately place API reprocessing process validation and commercially reprocessed lots on appropriate stability monitoring to demonstrate continued process capability throughout the lifecycle of the validated procedure. Additionally, retest periods for reference standards used in the quality control laboratory for analysis of APIs and API intermediates are not established with supporting analytical data.