# FDA 483 - Vitalant - December 17, 2021

Source: https://www.keypedia.com/records/483/vitalant/10f6f77c-7e31-4ded-8c06-3b55f90f8c9c

> FDA 483 for Vitalant on December 17, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitalant
- Inspection Date: 2021-12-17
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Vitalant, a blood bank in Granite Bay, CA, revealed a significant deficiency in record-keeping practices. The firm failed to adequately document donor travel and residence history during screening for malaria risk factors. This lapse in detailed record-keeping could compromise the complete history of work performed to ensure blood product safety.

## 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/45cab940-cb7c-41c3-bda5-aa5ae43b1fe8

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