FDA EIR - California Cryobank LLC d.b.a. Cooper Surgical - January 13, 2010

An FDA inspection of California Cryobank, Inc., located in New York, NY, was conducted on January 13, 2010. The inspection, part of the NYK-DO 2010 work plan and performed under Compliance Program C.P.7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), assessed the firm's operations for semen and testicular tissue. The regulatory framework for these operations falls under Section 361 of the Public Health Service Act and 21 CFR. While no formal FDA 483 (Inspectional Observations) was issued, several verbal observations were discussed with management. These included incomplete anonymous donor forms and inadequate screening procedures for Creutzfeldt-Jacob Disease (CJD), Xenotransplantation, and West Nile Virus. Concerns were also raised regarding the lack of current physical examinations for donors, insufficient security of the tissue bank room, absence of complete donor screening after six months, and incomplete documentation of ongoing donor eligibility decisions. Management acknowledged the observations and committed to implementing corrections. The firm, recently acquired by California Cryobank, was also in the process of synchronizing its procedures with the corporate office.