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

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.