# FDA 483 - Protein Sciences  Corporation - May 02, 2024

Source: https://www.globalkeysolutions.net/records/483/protein-sciences-corporation/99eff266-6766-4cf2-81af-eb0aace5280e

> FDA 483 for Protein Sciences  Corporation on May 02, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Protein Sciences  Corporation
- Inspection Date: 2024-05-02
- 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, revealed significant deficiencies in their manufacturing and quality control processes for Flublok drug products. Key issues included inadequate laboratory controls, failure to properly investigate deviations and out-of-specification results, and poor environmental monitoring and facility maintenance. These findings indicate a lack of robust quality systems impacting product quality and safety.

## Related Documents

- [483 - 2026-05-29](https://www.globalkeysolutions.net/records/483/protein-sciences-corporation/0712b41a-7d92-43d9-bc84-f3e35c873976)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)
- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

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