# FDA 483 - Tris Pharma Inc. - June 08, 2021

Source: https://www.keypedia.com/records/483/tris-pharma-inc/098768bd-1d13-4d69-b1b8-fded5b4315eb

> FDA 483 for Tris Pharma Inc. on June 08, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tris Pharma Inc.
- Inspection Date: 2021-06-08
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Tris Pharma Inc. in Monmouth Junction, NJ, from May to June 2021, revealed significant deficiencies across its quality system, facility maintenance, and manufacturing controls. Observations included inadequate quality unit procedures, failure to properly investigate product complaints and submit field alert reports, and issues with personnel gowning leading to product contamination. The findings highlight a systemic breakdown in ensuring drug product quality and safety.

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## Related Officers

- [Rose L. Jean-Mary](https://www.keypedia.com/people/rose-l-jean-mary/398483f5-12f7-429b-8a13-c068b41ff3ed)
- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)
- [Investigator](https://www.keypedia.com/people/jay-b-shah/c437fff9-807e-4dea-80c0-8f77850db6f8)
- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.keypedia.com/companies/tris-pharma-inc/65a6590a-3777-454b-bf0d-a9d37e3bf58e

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248