FDA Inspection 1268404 — MFC Lab, Inc.

MFC Lab, Inc. — FEI 3009682116

The FDA completed an inspection of MFC Lab, Inc. on April 30, 2025 in Greenbrae, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 30, 2025
Fiscal Year
2025
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Greenbrae, CA (United States)

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1223021 CFR 1271.50(a)Responsible person to determine, document