# FDA 483 - MFC Lab, Inc. - April 30, 2025

Source: https://www.globalkeysolutions.net/records/483/mfc-lab-inc/e5b7444e-d5ec-45d9-85d8-31744eb937db

> FDA 483 for MFC Lab, Inc. on April 30, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MFC Lab, Inc.
- Inspection Date: 2025-04-30
- Product Type: other
- Office Name: San Francisco District Office
- Summary: MFC Lab, Inc. in Greenbrae, CA, a reproductive tissue facility, was inspected by the FDA from 4/29/2025 to 4/30/2025. The inspection revealed two significant issues related to the determination of HCT/P donor eligibility and the lack of established procedures for screening directed semen donors. These observations indicate deficiencies in donor screening and documentation practices.

## Related Officers

- [Emily S. McGann](https://www.globalkeysolutions.net/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)

Company: https://www.globalkeysolutions.net/companies/mfc-lab-inc/ff483705-ea04-47d2-849c-1a57ff90d2f4

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df