# FDA 483 - Centrient Pharmaceuticals India Private Limited - Unknown Date

Source: https://www.keypedia.com/records/483/centrient-pharmaceuticals-india-private-limited/3afe6108-ef5a-4ed5-bda6-c8388fe92d10

> FDA 483 for Centrient Pharmaceuticals India Private Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Centrient Pharmaceuticals India Private Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: DSM Sinochem Pharmaceuticals India Private Limited, a drug substance manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included inadequate control of reprocessed materials leading to API contamination, failure of the quality unit to reject out-of-specification APIs, and incomplete batch production records. Additionally, the firm lacked proper validation for reprocessing methods and maintained insufficient laboratory control mechanisms, indicating a systemic breakdown in ensuring product quality and data integrity.

## Related Documents

- [483 - 2022-07-01](https://www.keypedia.com/records/483/centrient-pharmaceuticals-india-private-limited/33dbed4d-3126-4732-9fcc-03efc001d4a7)
- [WARNING_LETTER - 2022-07-01](https://www.keypedia.com/records/warning_letter/centrient-pharmaceuticals-india-private-limited/85b52ddf-4f33-4820-99cf-3ed61c6a346c)

## Related Officers

- [Patric C. Klotzbuecher](https://www.keypedia.com/people/patric-c-klotzbuecher/cbb2e6b5-b001-457e-9073-33535f02926e)

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