FDA EIR - California Cryobank, LLC - August 07, 2009

California Cryobank, Inc. underwent an FDA inspection from August 3 to August 7, 2009, as a Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) establishment. The inspection focused on compliance with current Good Tissue Practice (cGTP) regulations for its cord blood stem cell processing operations. The inspection identified seven significant observations documented on an FDA Form 483. Key issues included the company's failure to validate critical processing conditions to prevent contamination and cross-contamination of stem cell products, and the microbiological test methods used for both stem cells and reagents were not adequately validated. Furthermore, the company did not investigate positive microbiological cultures, implement corrective actions for quality issues, or perform environmental monitoring of its processing areas. Deficiencies were also noted in donor eligibility screening procedures, specifically the lack of defined investigation protocols for health questionnaire responses and an incomplete questionnaire design. Lastly, environmental controls lacked adequate cleaning procedures for equipment to ensure aseptic processing, with specific details like disinfectant contact times not being defined. In response to these findings, company management committed to providing a written reply to the FDA within 30 days, detailing completed or in-progress corrective actions. Management also agreed to consider implementing a procedure for requesting and documenting medical records from donor mothers to enhance the donor screening process. These actions are required to bring the facility into compliance with HCT/P regulatory requirements.