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

Source: https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/eb4b676b-5443-48b6-b0a3-98b4224ad468

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

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## Details

- Record Type: 483
- Company Name: Torrent Pharmaceuticals Limited
- Inspection Date: 2024-06-12
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in quality control, stability testing, and manufacturing practices.

**Key Violations and Observations:**

*   **Stability Testing Program Deficiencies:** No program exists to assess drug product stability, and the Quality Unit failed to ensure products sold in the US market are stable throughout their shelf life.
*   **Out-of-Trend (OOT) Results and Release:** 34 batches had valid OOT results for Assay by HPLC, 35 for Assay by HPLC 1, and 1 each for degradation impurities and Assay by HPLC, but were released and sold into the US market from October 2022 to May 2024, deviating from procedure CQA-070-06. The impact of these OOT results on product shelf life was not evaluated. Annual stability batches also showed valid OOT results on long-term stability, yet remained in the market.
*   **Historical Stability Trend Issues:** Historical stability trends revealed a potential for drug product assay to decrease, leading to a Field Alert Report (FAR) for Tablets USP on June 11, 2024, due to the risk of OOT transitioning to Out-of-Specification (OOS) before expiry.
*   **Unexpected Assay Increases:** Several lots showed unexpected increases in Assay by HPLC (e.g., +4% at 12 months, +

## 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/d64fcb0f-dc08-4674-8135-6053179cf27e)

## Related Officers

- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

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

Office: https://www.globalkeysolutions.net/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe