# FDA 483 - Protein Sciences  Corporation - May 29, 2026

Source: https://www.globalkeysolutions.net/records/483/protein-sciences-corporation/0712b41a-7d92-43d9-bc84-f3e35c873976

> FDA 483 for Protein Sciences  Corporation on May 29, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Protein Sciences  Corporation
- Inspection Date: 2026-05-29
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Protein Sciences Corporation in Pearl River, NY, a recombinant influenza virus manufacturer, revealed significant deficiencies. The firm was cited for incomplete and untimely complaint and deviation investigations, inadequate validation studies for raw materials, and a lack of quality oversight for contract services. Additionally, corrective and preventive actions were not implemented in a timely manner, indicating systemic issues in their quality management system.

## Related Documents

- [483 - 2024-05-02](https://www.globalkeysolutions.net/records/483/protein-sciences-corporation/99eff266-6766-4cf2-81af-eb0aace5280e)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/jacqueline-m-diaz-albertini/9ff937fe-4e9b-445a-80fa-e26800d923b8)

Company: https://www.globalkeysolutions.net/companies/protein-sciences-corporation/5a8e39ec-a92e-42d6-a577-365d1d089624

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961