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

Source: https://www.keypedia.com/records/483/mfc-lab-inc/065bbb04-6fff-4fed-b17e-15b3a12fed10

> FDA 483 for MFC Lab, Inc. on April 30, 2025. Product: biologics. 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: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: MFC Lab, Inc. in Greenbrae, CA, a reproductive tissue facility, received two observations during an FDA inspection. The firm failed to determine and document the eligibility of an HCT/P donor based on screening and testing results. Additionally, the firm did not establish and maintain procedures for screening HCT/P donors, specifically directed semen donors.

## Related Documents

- [483 - 2025-04-30](https://www.keypedia.com/records/483/mfc-lab-inc/e5b7444e-d5ec-45d9-85d8-31744eb937db)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b