# FDA 483 - Vitalant - June 12, 2025

Source: https://www.globalkeysolutions.net/records/483/vitalant/44d7f695-2211-4988-a89f-bf7335133ed0

> FDA 483 for Vitalant on June 12, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitalant
- Inspection Date: 2025-06-12
- Product Type: biologics
- Office Name: San Francisco District Office
- Summary: Vitalant, a blood bank in Brisbane, CA, was cited for significant deficiencies in record-keeping, investigation of unexplained discrepancies, and review of records prior to product release. These issues primarily concern the processing and release of irradiated blood products and Frozen Red Blood Cells, indicating systemic failures in maintaining adequate control over critical manufacturing and quality processes.

## Related Documents

- [483 - 2022-02-18](https://www.globalkeysolutions.net/records/483/vitalant/28674cd7-f309-49cf-ba8d-041d5564eee1)

## Related Officers

- [Esther A. Ofori](https://www.globalkeysolutions.net/people/esther-a-ofori/98108fae-1e09-4849-bceb-18e69dff7ba4)
- [William F. Lagud](https://www.globalkeysolutions.net/people/william-f-lagud/c90c4bd6-bb56-4a60-a5f8-cbc648bb8dbe)

Company: https://www.globalkeysolutions.net/companies/vitalant/f184cb37-ef39-4557-b97b-71b2baae5fef

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df