# Avera McKennan – FDA 483, Jun 23, 2026

Source: https://www.keypedia.com/records/483/avera-mckennan/95b8578c-cba5-4b6c-b4a7-496af88584cb

> FDA 483 for Avera McKennan on June 23, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avera McKennan
- Inspection Date: 2026-06-23
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.keypedia.com/companies/avera-mckennan/36957b1e-dde6-4d13-bd6c-f504efe5d0de

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d