# FDA 483 - Torrent Pharmaceuticals Limited - September 28, 2022

Source: https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/a32ea7e9-ac64-4685-8ffa-bdf3b3f40fbe

> FDA 483 for Torrent Pharmaceuticals Limited on September 28, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Torrent Pharmaceuticals Limited
- Inspection Date: 2022-09-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Torrent Pharmaceuticals Limited in Indrad, Gujarat, India, revealed significant deficiencies in equipment cleaning and maintenance, quality control investigations, and drug complaint handling. Observations included inadequate cleaning procedures leading to product cross-contamination, a systemic failure to thoroughly investigate unexplained discrepancies and out-of-specification results, and deficient investigations into product quality complaints. These issues indicate a lack of robust quality systems to ensure drug product safety, identity, strength, quality, and purity.

## 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 - 2024-06-12](https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/d64fcb0f-dc08-4674-8135-6053179cf27e)
- [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)
- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

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