California Cryobank LLC d.b.a. Cooper SurgicalJune 7, 2024

FDA 483 - California Cryobank LLC d.b.a. Cooper Surgical - June 07, 2024

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Record Details

An FDA inspection of California Cryobank LLC d.b.a. Cooper Surgical in New York, NY, identified a significant issue with donor screening practices. The firm was found to be using an abbreviated donor screening procedure for repeat semen donors who had not completed a full screening within the preceding six months. This practice raises concerns regarding the thoroughness of donor eligibility determination for reproductive human tissue.

Company: California Cryobank LLC d.b.a. Cooper Surgical
Inspection Date: June 7, 2024
Product Type: Biologics
Office: Division of Human and Animal Food Operations - East I
Person: Irina Gaberman (Investigator)

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ID · e5ff9d51-6929-451d-aaac-42426e95bd46