FDA EIR - California Cryobank LLC d.b.a. Cooper Surgical - July 25, 2022

An FDA inspection of California Cryobank LLC (CCB) in New York, NY, was conducted from July 22 to July 25, 2022. This routine inspection, part of the FY22 Office of Biological Products Operations workplan, focused on CCB's human reproductive tissue operations, specifically semen, and was performed under the regulatory framework of CP 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

The inspection reviewed CCB's processes for recovering, screening, packaging, processing, storing, labeling, and distributing anonymous, directed, and sexually intimate partner semen, as well as storing and distributing embryos, oocytes, and testicular tissues. A random review of anonymous and directed semen donor records from 2020-2022 found them to be adequate, with no significant deficiencies in donor testing or procedural compliance.

While no formal violations were identified, discussions included the importance of ensuring CCB's written procedures clearly differentiate and describe the assignment of unique identifier codes for anonymous versus directed semen donors, emphasizing that no donor code should be duplicated once assigned, regardless of the donor's eligibility status. CCB management committed to addressing this clarification.

Ultimately, no FDA Form 483 (Inspectional Observations) was issued, indicating that the facility was found to be in satisfactory compliance during this inspection.