# FDA 483 - Vitalant - May 15, 2019

Source: https://www.keypedia.com/records/483/vitalant/6a55d708-5ff0-4d57-ad48-946f145f69a3

> FDA 483 for Vitalant on May 15, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitalant
- Inspection Date: 2019-05-15
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of BloodSource, Inc. in Placerville, CA, conducted from May 14-15, 2019, revealed a significant failure in determining donor eligibility. The firm did not adequately assess a whole blood donor's travel history to malaria-endemic areas, using an outdated reference document and failing to properly document or search for travel locations. This lapse indicates a critical procedural deficiency in preventing the collection of potentially contaminated blood.

## Related Officers

- [Shelley H. Beausoleil](https://www.keypedia.com/people/shelley-h-beausoleil/1212116b-e24d-4bbc-a27a-5c16334d573e)

Company: https://www.keypedia.com/companies/vitalant/9164ea0a-e239-464b-ae59-3c1488db7a57

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