# FDA 483 - Protein Sciences  Corporation - March 17, 2026

Source: https://www.keypedia.com/records/483/protein-sciences-corporation/8fb334bf-0e5f-43b7-b446-f95767939025

> FDA 483 for Protein Sciences  Corporation on March 17, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Protein Sciences  Corporation
- Inspection Date: 2026-03-17
- 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 manufacturer of Flublok recombinant influenza vaccine, revealed significant deficiencies across multiple areas. Observations included inadequate inventory controls for critical starting materials, unvalidated computerized systems for quality data, and failures in preventing microbiological contamination due to poor material flow, aseptic technique, and equipment maintenance. Additionally, the Quality Unit demonstrated a lack of effective oversight in addressing recurring deviations.

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## Related Officers

- [Christian Lynch](https://www.keypedia.com/people/christian-lynch/ee342d8e-9fcf-4c84-9494-ceaf6320faf6)
- [Richard L. Bartlett](https://www.keypedia.com/people/richard-l-bartlett/602337b9-ac77-41bb-a254-71a9d345335b)
- [Matthew J Grothkievicz](https://www.keypedia.com/people/matthew-j-grothkievicz/421c244d-2e45-4ab9-a1c8-bd14452e7b9c)

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

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