# FDA 483 - Centrient Pharmaceuticals India Private Limited - January 27, 2026

Source: https://www.keypedia.com/records/483/centrient-pharmaceuticals-india-private-limited/6339f67d-3661-4b03-9ff4-0ea6ed8d84d5

> FDA 483 for Centrient Pharmaceuticals India Private Limited on January 27, 2026. 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: 2026-01-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Centrient Pharmaceuticals India Private Limited in Toansa, India, received a Form 483 with three observations related to significant manufacturing deficiencies. The inspection revealed severe issues with equipment cleaning, leading to cross-contamination and residual materials, as well as failures in preventing contamination of APIs by foreign particles from worn equipment and inadequate environmental monitoring. These issues pose a substantial risk to product quality and patient health.

## 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)
- [483 - Unknown Date](https://www.keypedia.com/records/483/centrient-pharmaceuticals-india-private-limited/3afe6108-ef5a-4ed5-bda6-c8388fe92d10)

## Related Officers

- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8