# FDA 483 - ImpactLife - May 09, 2025

Source: https://www.globalkeysolutions.net/records/483/impactlife/605a04d5-24e3-40d5-b34e-ff0a72bbfc66

> FDA 483 for ImpactLife on May 09, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ImpactLife
- Inspection Date: 2025-05-09
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: ImpactLife in Monona, WI, was inspected from May 8-9, 2025, and received one observation. The inspection found that written standard operating procedures for the storage and distribution of blood and blood components were not always followed. Specifically, visual inspections of relocated Red Blood Cell units were not performed as required by SOP 8222, despite being documented as acceptable.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.globalkeysolutions.net/companies/impactlife/26c13394-fea4-4a9b-ab74-e8a9feb8915d

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