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# Aurobindo FDA-483 Released
- URL: https://www.fdaweb.com/aurobindo-fda-483-released/
- Published: 2017-05-10T12:00:00.000Z
- Updated: 2026-09-14T22:22:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138662

FDA has published the FDA-483 issued to Aurobindo Pharma, Hyderabad, Telangana, India, following a 4/30-4/28 agency inspection. Specific violations noted on the [form](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM557175.pdf?ref=fdaweb.com) were: 

- failing to maintain in a good state of repair buildings used in the manufacturing of a drug product;
- failing to include in laboratory controls establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of strength, identity, quality, and purity;
- failing to have changes to written procedures drafted, reviewed, and approved by the appropriate organizational unit;
- failing to thoroughly review whether or not a batch has already been distributed;
- failing to have equipment used in the manufacture, processing, packing, or holding of drug products be of appropriate design to facilitate operations for its intended use;
- 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
- failing to establish procedures to prevent microbiological contamination of drug products purporting to be sterile.