# FDA 483 - Torrent Pharmaceuticals Limited - December 11, 2023

Source: https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/8aec8954-11d2-499d-9063-1cc79c1c2c4c

> FDA 483 for Torrent Pharmaceuticals Limited on December 11, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Torrent Pharmaceuticals Limited
- Inspection Date: 2023-12-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Torrent Pharmaceuticals Limited in Chhatral, Gujarat, India, revealed significant deficiencies across quality control, equipment management, and manufacturing processes. The firm failed to thoroughly investigate out-of-specification results, lacked proper qualification and maintenance for equipment, and did not adequately validate test methods. These issues indicate a compromised quality system that could impact the safety and quality of drug products.

## Related Documents

- [483 - 2023-12-11](https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/b5da81d7-8b10-4853-b9dd-786cae23215e)

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.globalkeysolutions.net/companies/torrent-pharmaceuticals-limited/f6a46248-6051-4cd6-8fa4-220f0a33652c

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