# FDA 483 - Torrent Pharmaceuticals Limited - June 12, 2024

Source: https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/d64fcb0f-dc08-4674-8135-6053179cf27e

> FDA 483 for Torrent Pharmaceuticals Limited on June 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Torrent Pharmaceuticals Limited
- Inspection Date: 2024-06-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Torrent Pharmaceuticals Limited, an API and finished product manufacturer in Indrad, Gujarat, India, received five observations during an FDA inspection. Key findings include a deficient stability testing program, failure to thoroughly investigate out-of-trend and out-of-specification results, and inadequate equipment cleaning procedures. These issues indicate significant concerns regarding drug product quality, safety, and overall quality system oversight.

## Related Documents

- [483 - 2017-04-28](https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/21ec96a8-6c9e-44e3-ba1c-44c78d7f976b)
- [483 - 2019-04-16](https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/b67909ff-4b66-4b17-bd05-0ca19752ad67)
- [483 - 2019-04-16](https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/32b739d4-b55c-4f77-9cf6-595e6bbeea6f)
- [483 - 2022-09-28](https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/a32ea7e9-ac64-4685-8ffa-bdf3b3f40fbe)
- [483 - 2024-06-12](https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/eb4b676b-5443-48b6-b0a3-98b4224ad468)

## Related Officers

- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [Steven A. Breitfeller](https://www.globalkeysolutions.net/people/steven-a-breitfeller/78d7da40-3d0a-42e6-a2ad-93142bd69e8a)

Company: https://www.globalkeysolutions.net/companies/torrent-pharmaceuticals-limited/801e26ba-26ed-40ab-84c9-d4ee2e24e42e

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