# FDA 483 - Centaur Pharmaceuticals Private Ltd. - February 08, 2023

Source: https://www.globalkeysolutions.net/records/483/centaur-pharmaceuticals-private-ltd/98584b2b-2cba-4624-b2e0-199de4978457

> FDA 483 for Centaur Pharmaceuticals Private Ltd. on February 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Centaur Pharmaceuticals Private Ltd.
- Inspection Date: 2023-02-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Centaur Pharmaceuticals Private Ltd. in Hinjewadi, India, was cited with four observations during an FDA inspection, revealing significant deficiencies in equipment cleaning and design, leading to potential cross-contamination of drug products. The firm's laboratory controls were also found to be inadequate, including issues with analytical method validation and insufficient investigation into extraneous peaks. These findings indicate a serious lack of adherence to cGMP regulations, impacting product quality and patient safety.

## Related Documents

- [WARNING_LETTER - 2022-11-21](https://www.globalkeysolutions.net/records/warning_letter/centaur-pharmaceuticals-private-ltd/7ee96bde-031f-4864-88cf-4d59eb303aa3)
- [WARNING_LETTER - 2023-02-08](https://www.globalkeysolutions.net/records/warning_letter/centaur-pharmaceuticals-private-ltd/d354c72b-fa2f-45ff-a7b3-c1fa16a67588)

## Related Officers

- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.globalkeysolutions.net/companies/centaur-pharmaceuticals-private-ltd/65d235da-0400-49d7-acff-38fe013fc5b4

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