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# FDA-483 Shows Violations at India’s Hetero Labs
- URL: https://www.fdaweb.com/fda-483-shows-violations-at-indias-hetero-labs/
- Published: 2017-01-24T12:00:00.000Z
- Updated: 2026-09-14T22:02:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137812

FDA has released the [FDA-483](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM537060.pdf?ref=fdaweb.com) issued after a 12/7-12/16/16 agency inspection at Hetero Labs, Polepally Village, India. Inspection observations included: 

- failing to fully follow the responsibilities and procedures applicable to the quality control unit;
- failing to prepare batch production and control records for each batch of drug product and failing to include in them complete information relating to the production and control of each batch;
- failing to include in written records of investigation of a drug complaint the findings of the investigation and the follow-up;
- failing to maintain at the establishment where an investigation occurred the written record or copy of the record of an investigation of a complaint conducted in relation to any unexplained discrepancy;
- failing to clean and maintain at appropriate intervals equipment and utensils to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
- failing to document deviations from production time limits;
- failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods; and
- 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.