# FDA 483 - Torrent Pharmaceuticals Limited - April 16, 2019

Source: https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/32b739d4-b55c-4f77-9cf6-595e6bbeea6f

> FDA 483 for Torrent Pharmaceuticals Limited on April 16, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Torrent Pharmaceuticals Limited
- Inspection Date: 2019-04-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Torrent Pharmaceuticals Limited received a Form 483 citing significant deficiencies in quality control and manufacturing processes. Observations included failures in thoroughly investigating out-of-specification results, lack of adequate written procedures for process controls, and deficient routine calibration and qualification of manufacturing equipment. These issues indicate a systemic breakdown in ensuring product quality and compliance.

## 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 - 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)
- [483 - 2024-06-12](https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/eb4b676b-5443-48b6-b0a3-98b4224ad468)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/zhao-wang/51081e23-1891-4c93-9488-f578511e0a0e)
- [Jogy George](https://www.globalkeysolutions.net/people/jogy-george/00ef0915-66d2-4b34-9b74-d1e08caf2db3)
- [Lata C. Mathew](https://www.globalkeysolutions.net/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)

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