# FDA 483 - Dept. of the Army - Armed Services Blood Bank Ctr. - Europe - August 23, 2023

Source: https://www.keypedia.com/records/483/dept-of-the-army-armed-services-blood-bank-ctr-europe/1a0ec5e7-01ff-4020-8274-3d312e704ccb

> FDA 483 for Dept. of the Army - Armed Services Blood Bank Ctr. - Europe on August 23, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dept. of the Army - Armed Services Blood Bank Ctr. - Europe
- Inspection Date: 2023-08-23
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of the Dept. of the Army - Armed Services Blood Bank Ctr. - Europe in Landstuhl, Germany, revealed a significant deficiency related to the investigation and follow-up of adverse donor reactions. The facility failed to prepare and maintain written reports of these investigations, including conclusions and follow-up actions. This indicates a serious lapse in donor safety protocols and record-keeping.

## Related Officers

- [investigator](https://www.keypedia.com/people/mizanne-e-lewis/c79964ac-5163-44a2-89e9-8cc8775de9b4)

Company: https://www.keypedia.com/companies/dept-of-the-army-armed-services-blood-bank-ctr-europe/dacd6f63-5b11-4f1a-9146-4f18a0da4ffd

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321