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# 2 Observations in Lupin FDA-483
- URL: https://www.fdaweb.com/2-observations-in-lupin-fda-483/
- Published: 2019-02-19T12:00:00.000Z
- Updated: 2026-09-15T01:05:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143416

FDA has released the FDA-483 containing two observations from a 1/28-2/8 inspection at Lupin Limited, a Goa, India, drug product manufacturer. The 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 been already distributed; and
- failing to have written procedures for production and process controls designed to assure that drug products have the identity, strength, quality, and purity they purport or are represented to possess.