# FDA 483 - Avantor Inc. - May 27, 2025

Source: https://www.globalkeysolutions.net/records/483/avantor-inc/9a1900f5-cdc4-41fa-9589-e6108fa4a2d2

> FDA 483 for Avantor Inc. on May 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avantor Inc.
- Inspection Date: 2025-05-27
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Avantor Performance Materials, LLC in Phillipsburg, NJ, an API manufacturer, identified one observation. The firm was cited for not verifying the suitability of test methods for active pharmaceutical ingredients under actual conditions of use. Specifically, analytical method verification studies for USP methods used in release and stability testing for API products marketed in the U.S. were not completed.

## Related Officers

- [Robin P. Mathew](https://www.globalkeysolutions.net/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)

Company: https://www.globalkeysolutions.net/companies/avantor-inc/d47a07ba-3a58-4e37-84ec-dd93b3d815db

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