Vascular Solutions, Inc. – FDA 483
An FDA inspection of Vascular Solutions LLC in Maple Grove, MN, a freeze-dried plasma manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate validation studies for microbial ingress prevention, deficient equipment cleaning procedures, and a lack of cleaning agent effectiveness studies. Additionally, environmental monitoring samples were not representative, and shipping container temperatures were not monitored, indicating potential risks to product quality and safety.
- Company
- Vascular Solutions, Inc.
- Product type
- biologics
ID · 27ba1f17-cf27-45ec-bb04-2e9946aaff9d
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