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# Aurobindo Pharma FDA-483
- URL: https://www.fdaweb.com/aurobindo-pharma-fda-483/
- Published: 2022-05-24T12:00:00.000Z
- Updated: 2026-09-14T17:45:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151893

FDA has released the FDA-483 issued following a 5/2-5/10 inspection at Aurobindo Pharma, a drug manufacturer in Mahaboob Nagar, Telangana, India. The inspection observations were: 

- investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy;
- failing to have written procedures and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- batch production and control records do not include complete information relating to the production and control of each batch;
- failing to follow the written stability program;
- 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; and
- equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use.