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483
•California Cryobank, LLC•February 27, 2025

California Cryobank, LLC – FDA 483, Feb 27, 2025

Record Details

During an inspection, California Cryobank, LLC, a reproductive firm in Los Altos, CA, received one observation. The firm was cited for shipping anonymous semen vials, classified as HCT/Ps, while they were still in quarantine and awaiting donor eligibility determinations. These shipments lacked the required accompanying records indicating that donor eligibility had not yet been completed.

Company
California Cryobank, LLC
Inspection date
February 27, 2025
Product type
biologics
Office
San Francisco District Office
Person
  • Emily B. Camire
View Company Profile

ID · f849e642-4769-4e9c-adb1-508b90b7630a

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