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# FDA Releases Lupin Limited FDA-483
- URL: https://www.fdaweb.com/fda-releases-lupin-limited-fda-483/
- Published: 2019-02-12T12:00:00.000Z
- Updated: 2026-09-15T01:03:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143360

FDA has released the FDA-483 issued following a 1/14-1/25 inspection at Lupin Limited, a Madhya Pradesh, India, drug manufacturer. Specific inspection observations listed on the form 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;
- failing to have written records of investigations of a drug complaint include findings of the investigation and the follow-up;
- employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions;
- failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records are instituted only by authorized personnel;
- equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use; and
- established laboratory control mechanisms are not documented at the time of performance.