FDA EIR - California Cryobank LLC d.b.a. Cooper Surgical - July 09, 2019

A comprehensive FDA inspection of California Cryobank LLC, a human reproductive tissue establishment in New York, NY, was conducted from July 2 to July 9, 2019. The inspection, performed under Compliance Program 7341.002 for Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps), focused on the firm's operations as a sperm bank. This included the collection, screening, testing, cryopreservation, storage, and distribution of anonymous and directed sperm donations, as well as the storage and distribution of oocytes and embryos. Key areas reviewed included donor eligibility, screening, testing protocols, recovery, storage, labeling, distribution, and quarantine practices.

During the inspection, it was noted that the firm had discontinued its anonymous egg donor program at this New York location as of June 2019. Testing services were contracted to CLIA-certified laboratories, and standard operating procedures were reviewed. Crucially, the inspection concluded with no major violations; "No Form FDA 483, Inspectional Observations was issued to the firm at this time," indicating compliance with the regulatory framework. Management was advised to update their operational functions during the 2020 FDA re-registration to accurately reflect changes, particularly the discontinuation of the anonymous egg donor program.