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# Torrent Pharmaceuticals FDA-483
- URL: https://www.fdaweb.com/torrent-pharmaceuticals-fda-483/
- Published: 2024-01-03T12:00:00.000Z
- Updated: 2026-09-14T14:19:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156068

FDA has released the form FDA-483 with five inspection observations that was issued to Torrent Pharmaceuticals following a 12/5-12/11/2023 at its drug manufacturing facility in Gujarat, India. The five inspection [observations](fda.gov/media/175134/download?attachment) 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 distributed;
- failing to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit for formulation manufacturing operations;
- failing to clean and maintain equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
- components for drug product manufacturing are not weighed and measured; and
- failing to establish the accuracy, sensitivity, specificity, and reproducibility of test methods.