# FDA 483 - Vitalant - July 24, 2019

Source: https://www.keypedia.com/records/483/vitalant/01a790a1-5e49-441a-a922-44a6eef31510

> FDA 483 for Vitalant on July 24, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitalant
- Inspection Date: 2019-07-24
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Vitalant's Blood Bank Corporate Office in Scottsdale, AZ, revealed a significant issue with their electronic donor management system. The system failed to properly identify duplicate donor records, leading to a failure in maintaining accurate records of ineligible or deferred donors. This deficiency could potentially compromise donor eligibility screening and product safety.

## Related Officers

- [Bryce A. May](https://www.keypedia.com/people/bryce-a-may/39683196-5fff-4608-808c-7f10df606f7b)
- [investigator](https://www.keypedia.com/people/marc-a-jackson/3bb8df6e-ab3a-4106-9a4b-aaaa307bc051)
- [Consumer Safety](https://www.keypedia.com/people/kip-j-hanks/839cb755-ff60-448c-9b21-b84b78b59a15)

Company: https://www.keypedia.com/companies/vitalant/22d14b59-7237-4669-8216-ec5ca5dd7434

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6