# FDA 483 - Vitalant - May 02, 2022

Source: https://www.keypedia.com/records/483/vitalant/85e618ca-966e-4437-94f9-68872ff12b9b

> FDA 483 for Vitalant on May 02, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitalant
- Inspection Date: 2022-05-02
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Vitalant's Donor Collection Center in Yuba City, CA, revealed two observations related to procedural non-compliance. The firm failed to consistently follow manufacturer instructions for arm preparation applicators and did not adhere to its own written standard operating procedures for blood collection. These issues indicate a lack of strict adherence to established protocols during donor blood collection.

## Related Officers

- [Shelley H. Beausoleil](https://www.keypedia.com/people/shelley-h-beausoleil/1212116b-e24d-4bbc-a27a-5c16334d573e)
- [Richard L. Bartlett](https://www.keypedia.com/people/richard-l-bartlett/602337b9-ac77-41bb-a254-71a9d345335b)

Company: https://www.keypedia.com/companies/vitalant/b084da68-1b6a-475d-950c-52cc220846dd

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b