483
Avera McKennanAvera McKennan – FDA 483, Jun 23, 2026
Record Details
An FDA inspection of Avera McKennan, a donor center in Sioux Falls, SD, identified a significant issue regarding the improper use of supplies and reagents during venipuncture. Specifically, phlebotomists failed to follow manufacturer instructions and the firm's own SOP for venipuncture site preparation, potentially compromising donor safety and product quality. This indicates a moderate severity finding related to procedural non-compliance.
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ID · 95b8578c-cba5-4b6c-b4a7-496af88584cb
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