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# Jubilant Generics FDA-483
- URL: https://www.fdaweb.com/jubilant-generics-fda-483/
- Published: 2022-10-25T12:00:00.000Z
- Updated: 2026-09-14T18:04:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153047

FDA has released the form FDA-483 issued following a 7/20-8/1 inspection at Jubilant Generics, a Uttaranchal, India, drug manufacturer. The six inspection observations 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 already been distributed;
- written records are not always made of investigations into unexplained discrepancies;
- written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up;
- the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed;
- established laboratory control mechanisms are not followed and documented at the time of performance; and
- batch production and control records do not include complete information relating to the production and control of each batch.