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# Dr. Reddy’s FDA-483
- URL: https://www.fdaweb.com/dr-reddys-fda-483/
- Published: 2019-02-26T12:00:00.000Z
- Updated: 2026-09-15T01:07:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143474

FDA has released the FDA-483 issued following a 1/7-1/15 inspection at the Dr. Reddy’s Laboratories facility in Andhra, Pradesh, India. The four inspection observations in the [report](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM632054.pdf?ref=fdaweb.com) were: 

- failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed;
- failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
- failing to have laboratory controls include establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failing to follow written production and process control procedures in the execution of production and process controls functions and failing to document them at the time of performance.