California Cryobank LLC – FDA EIR, Apr 10, 2008

An FDA inspection of California Cryobank, Inc.'s Cambridge, MA facility occurred from April 2 to April 10, 2008. The inspection, conducted under the regulatory framework for Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) as per 21 CFR 1271.10, reviewed the processes for donor semen—including donation, processing, storage, and release. While no formal regulatory violations warranting an FDA Form 483 were issued, several observations were discussed with management.

Key issues included an open window between the laboratory and the supervisor's office, posing a potential environmental control concern. Discrepancies in donor height information were noted between the company catalog and medical records. It was also observed that contract physicians' agreements were signed prior to the latest Physical Exam Procedure, and documentation was missing to confirm they had reviewed the updated Standard Operating Procedure. A donor with new ear piercings lacked the required follow-up information as per company policy. Additionally, some data entry inconsistencies were identified in problem logs, and an outdated inventory shipping form was in use. Management acknowledged these observations and provided assurance that they would be addressed internally.