483
Dept. of the Army - Armed Services Blood Bank Ctr. - EuropeDept. of the Army - Armed Services Blood Bank Ctr. - Europe – FDA 483, Aug 23, 2023
Record Details
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.
- Inspection date
- August 23, 2023
- Product type
- biologics
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