# FDA 483 - Torrent Pharmaceuticals Limited - May 25, 2023

Source: https://www.keypedia.com/records/483/torrent-pharmaceuticals-limited/e89de731-95dc-46e5-a208-514016470cd1

> FDA 483 for Torrent Pharmaceuticals Limited on May 25, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Torrent Pharmaceuticals Limited
- Inspection Date: 2023-05-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Torrent Pharmaceuticals Limited in Bharuch, Gujarat, India, revealed significant deficiencies in their manufacturing processes. The firm failed to thoroughly investigate unexplained discrepancies, establish scientifically justified root causes for deviations, and extend investigations to potentially impacted batches. Additionally, inadequate controls over computerized systems for record-keeping were observed, indicating a lack of data integrity.

## Related Documents

- [483 - 2019-03-18](https://www.keypedia.com/records/483/torrent-pharmaceuticals-limited/1cf84d55-8ee9-4d2f-be5c-beebf6072986)

## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.keypedia.com/companies/torrent-pharmaceuticals-limited/7d8d0f1a-2012-47a6-99c8-10c2953c39af

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1