# FDA 483 - Centrient Pharmaceuticals India Private Limited - July 01, 2022

Source: https://www.keypedia.com/records/483/centrient-pharmaceuticals-india-private-limited/33dbed4d-3126-4732-9fcc-03efc001d4a7

> FDA 483 for Centrient Pharmaceuticals India Private Limited on July 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Centrient Pharmaceuticals India Private Limited
- Inspection Date: 2022-07-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Centrient Pharmaceuticals India Private Limited, an API manufacturer in Dist. SBS Nagar, revealed significant deficiencies across its operations. The firm exhibited inadequate quality control, poor data integrity, and failures in validating critical manufacturing processes and equipment. These issues collectively indicate a lack of robust quality management and control over the production of active pharmaceutical ingredients.

## Related Documents

- [WARNING_LETTER - 2022-07-01](https://www.keypedia.com/records/warning_letter/centrient-pharmaceuticals-india-private-limited/85b52ddf-4f33-4820-99cf-3ed61c6a346c)
- [483 - Unknown Date](https://www.keypedia.com/records/483/centrient-pharmaceuticals-india-private-limited/3afe6108-ef5a-4ed5-bda6-c8388fe92d10)

## Related Officers

- [Marcellinus D. Dordanou, CSO](https://www.keypedia.com/people/marcellinus-d-dordanou-cso/2000caed-aca7-4824-9d55-f5251fdb190c)
- [Joel D. Hustedt](https://www.keypedia.com/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)

Company: https://www.keypedia.com/companies/centrient-pharmaceuticals-india-private-limited/cb4cf503-2578-4e8f-b226-d736e975468e

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