# FDA 483 - Centaur Pharmaceuticals Private Limited - January 13, 2023

Source: https://www.keypedia.com/records/483/centaur-pharmaceuticals-private-limited/bff26d77-e327-4f7c-a0c0-b30548dd6dbc

> FDA 483 for Centaur Pharmaceuticals Private Limited on January 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Centaur Pharmaceuticals Private Limited
- Inspection Date: 2023-01-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Centaur Pharmaceuticals Private Limited, a non-sterile drug manufacturer in Tuem, Goa, India, was inspected by the FDA from January 9-13, 2023. The inspection revealed significant deficiencies in laboratory controls, stability testing, microbial control procedures, and cleaning validation. These issues collectively indicate a need for comprehensive improvements in their quality control and production processes to ensure drug product identity, strength, quality, and purity.

## Related Officers

- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

Company: https://www.keypedia.com/companies/centaur-pharmaceuticals-private-limited/429667f3-78f8-45f1-b2ac-da0509f3e48d

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