# FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC - December 17, 2025

Source: https://www.keypedia.com/records/483/wyeth-pharmaceutical-division-of-wyeth-holdings-llc/39d24d4d-e40b-4581-a86f-6b53282ca2d4

> FDA 483 for Wyeth Pharmaceutical Division of Wyeth Holdings LLC on December 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wyeth Pharmaceutical Division of Wyeth Holdings LLC
- Inspection Date: 2025-12-17
- Product Type: drugs
- Office Name: New York District Office
- Summary: Wyeth Pharmaceutical Division of Wyeth Holdings, Llc in Pearl River, NY, received a Form 483 for significant deficiencies in its manufacturing processes for sterile drug products. Observations included inadequate validation of aseptic processes, deficient sterilization testing methods, and insufficient sampling of incoming components. The findings indicate a lack of robust controls to prevent microbiological contamination and ensure product quality.

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## Related Officers

- [Amal H Markum](https://www.keypedia.com/people/amal-h-markum/1c08fc04-2fc3-4f37-abfb-50dba4c00fd6)
- [Amatul H. Marium](https://www.keypedia.com/people/amatul-h-marium/5db400ce-ffde-4310-82f8-766fd2458a4d)
- [investigator](https://www.keypedia.com/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)
- [Luxuly Abraham](https://www.keypedia.com/people/luxuly-abraham/d33e3164-ec89-488b-bab9-a9ec30544970)

Company: https://www.keypedia.com/companies/wyeth-pharmaceutical-division-of-wyeth-holdings-llc/85fd73c7-1b97-4ac5-bc70-53dfb31c37e5

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d