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# Torrent Pharmaceuticals FDA-483 Out
- URL: https://www.fdaweb.com/torrent-pharmaceuticals-fda-483-out/
- Published: 2019-05-07T12:00:00.000Z
- Updated: 2026-09-15T01:24:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144049

FDA has released the FDA-483 issued following a 4/8-4/16 inspection at Torrent Pharmaceuticals, Indrad, Gujarat, India. The four inspection observations on the [form](https://www.fda.gov/media/124458/download?ref=fdaweb.com) 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 procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- failing to perform routine calibration of automatic and electronic equipment according to a written program designed to assure proper performance; and
- out-of-specification investigation for active pharmaceutical ingredient products is deficient.