# FDA 483 - Meriter Health Enterprises - May 07, 2025

Source: https://www.globalkeysolutions.net/records/483/meriter-health-enterprises/73fdd1e0-3d9a-4b20-9177-43a914699d69

> FDA 483 for Meriter Health Enterprises on May 07, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Meriter Health Enterprises
- Inspection Date: 2025-05-07
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Meriter Health Enterprises' Blood Bank in Madison, WI, revealed significant deficiencies in establishing and following scientifically sound procedures for blood component preparation and distribution. The inspection also identified failures in maintaining adequate quality control and general records, indicating a moderate level of non-compliance with regulations critical for ensuring the safety and quality of blood products.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/meriter-health-enterprises/233b96b5-4278-41fc-a17a-08a79c03e199

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