# FDA 483 - Versiti Michigan Inc - October 30, 2019

Source: https://www.keypedia.com/records/483/versiti-michigan-inc/7c34bcca-be61-4dbb-a633-4170ef5346a9

> FDA 483 for Versiti Michigan Inc on October 30, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Versiti Michigan Inc
- Inspection Date: 2019-10-30
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Versiti Michigan Inc. in Saginaw, MI, from October 26-30, 2019, revealed significant deviations from written standard operating procedures. Staff failed to consistently follow procedures during automated apheresis collection and donor screening, impacting alarm responses, documentation, needle adjustments, and donor vital sign measurements. These findings indicate a lack of adherence to established protocols for blood and blood component collection.

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## Related Officers

- [Susan M North](https://www.keypedia.com/people/susan-m-north/28518e5b-45b9-4405-a033-baa1cdb1bdc6)

Company: https://www.keypedia.com/companies/versiti-michigan-inc/40bf6484-1632-4707-88ce-353674bf1b99

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0