# FDA 483 - Centaur Pharmaceuticals Private Ltd. - November 21, 2022

Source: https://www.globalkeysolutions.net/records/483/centaur-pharmaceuticals-private-ltd/4a591dbb-e749-4fd1-9802-57abaa2496e6

> FDA 483 for Centaur Pharmaceuticals Private Ltd. on November 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Centaur Pharmaceuticals Private Ltd.
- Inspection Date: 2022-11-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Centaur Pharmaceuticals Private Ltd. in Ambernath, India, revealed severe data integrity issues, including the destruction of original GMP documents, widespread inaccurate and non-contemporaneous record-keeping, and a lack of electronic data controls. The firm also demonstrated significant deficiencies in OOS investigations, facility and equipment maintenance, analytical method validation, and overall quality unit oversight. These findings indicate a critical breakdown in the company's quality management system.

## Related Documents

- [483 - 2025-07-25](https://www.globalkeysolutions.net/records/483/centaur-pharmaceuticals-private-ltd/6c217560-02bc-4554-9c90-7d29e514896c)

## Related Officers

- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.globalkeysolutions.net/companies/centaur-pharmaceuticals-private-ltd/f96f4f92-5b20-4b5d-91d8-5b0dbe430494

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