# FDA 483 - Versiti Michigan Inc - April 11, 2025

Source: https://www.keypedia.com/records/483/versiti-michigan-inc/3808dcd6-7933-44f0-a852-1d31bbc3aa8a

> FDA 483 for Versiti Michigan Inc on April 11, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Versiti Michigan Inc
- Inspection Date: 2025-04-11
- Product Type: biologics
- Office Name: Detroit District Office
- Summary: Between April 9 and April 11, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of the Versiti Michigan, Inc. donor center located in Traverse City, Michigan. The inspection was carried out under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. The primary violation identified during the site visit involved a significant failure in recordkeeping practices. Specifically, the facility did not adhere to the requirement of retaining records for ten years after processing activities are completed. Investigators found that cleaning records for a specific apheresis collection machine were missing for nine of the twenty-seven months reviewed, representing a data gap of approximately 33.3% since January 2023. These missing documents are critical for verifying the sanitary maintenance of equipment used in donor services. While this Form FDA 483 does not constitute a final agency determination of non-compliance, it requires the company to take action. Versiti Michigan, Inc. is expected to respond by either disputing the findings or, more typically, submitting a formal corrective action plan to the FDA. This plan should detail how the facility will rectify the documentation gaps and ensure future compliance with federal record retention standards.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/matthew-j-gretkierewicz/d2b43230-5324-44e0-9cd0-7e40464bf5b0)

Company: https://www.keypedia.com/companies/versiti-michigan-inc/92afd2ec-cf7c-4c68-be48-a11621550964

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03