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# 3 Observations on Lupin FDA-483
- URL: https://www.fdaweb.com/3-observations-on-lupin-fda-483/
- Published: 2019-10-10T12:00:00.000Z
- Updated: 2026-09-15T01:55:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145213

FDA has released the FDA-483 issued following a 9/16-9/20 inspection at the Lupin API manufacturing facility in Maharashtra, India. The three inspection observations on the form were: 

- failing to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed;
- batch production and control records do not include complete information relating to the production and control of each batch; and
- failing to handle and store cleaned utensils in a manner to prevent contamination.