# Vascular Solutions, Inc. – FDA 483

Source: https://www.keypedia.com/records/483/vascular-solutions-inc/27ba1f17-cf27-45ec-bb04-2e9946aaff9d

> FDA 483 for Vascular Solutions, Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vascular Solutions, Inc.
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

## Related Documents

- [483 - 2025-10-10](https://www.keypedia.com/records/483/vascular-solutions-inc/a6b3bf6a-7e43-4cd4-8d18-db4403c97033) — date: October 10, 2025

## Related Officers

- [Ou Ma](https://www.keypedia.com/people/ou-ma/82b7c33c-1a3a-45ba-9d6f-f480d5b2abb4)
- [Shawn Fulwood](https://www.keypedia.com/people/shawn-fulwood/ab44d8b4-cd91-430b-b776-6db41d0a14db)
- [Alvia De Boli](https://www.keypedia.com/people/alvia-de-boli/d9b16fbe-c45d-416e-9b57-c24aa1216acf)

Company: https://www.keypedia.com/companies/vascular-solutions-inc/ed642941-14ea-433f-babb-d2a294f3699d

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4