# FDA 483 - Vitalant - February 07, 2025

Source: https://www.keypedia.com/records/483/vitalant/a703554c-eca6-445a-8db5-27d82e4c4567

> FDA 483 for Vitalant on February 07, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitalant
- Inspection Date: 2025-02-07
- Product Type: biologics
- Office Name: Denver District Office
- Summary: Vitalant, a blood bank in Denver, CO, was cited for multiple deficiencies during an FDA inspection. Observations included failures in record-keeping for blood component processing and emergency transfusions, inadequate investigation of positive bacterial results in platelets, insufficient review of records before product release, and poor facility maintenance and donor screening privacy. These issues indicate significant concerns regarding quality control, documentation practices, and facility standards.

## Related Officers

- [Conor J. Mccarron](https://www.keypedia.com/people/conor-j-mccarron/280401e4-b080-4ba8-ab35-d3b16e91c2b1)
- [FDA_PERSONNEL](https://www.keypedia.com/people/deepa-e-vadakkan/89c0e1c7-4f9e-4668-81a8-e5a9ab6a0e34)
- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/vitalant/11d8f82e-b4ab-4131-861b-263548210545

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face