> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Torrent Pharmaceuticals FDA-483
- URL: https://www.fdaweb.com/torrent-pharmaceuticals-fda-483-2/
- Published: 2024-06-27T12:00:00.000Z
- Updated: 2026-09-14T14:34:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157271

FDA has released the form FDA-483 issued following a 6/3-6/12 inspection at the Torrent Pharmaceuticals finished product and non-sterile active pharmaceutical ingredient manufacturing facility in Indrad, Gujarat, India. The inspection [observations](https://www.fda.gov/media/179610/download?ref=fdaweb.com) were:

- failure to have a testing program to assess the stability characteristics of drug products;
- failure 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 (repeat observation);
- failure to clean and maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product (repeat observation);
- failure to establish written procedures for the testing of materials as well as recording or storage of laboratory data; and
- failure to maintain an adequate clean washing facility for personnel.