FDA EIR - Cryo-Cell International, Inc - February 06, 2018

Cryo-Cell International, Inc., located in Oldsmar, FL, underwent a comprehensive FDA inspection from February 5-6, 2018. This inspection focused on biologics regulations governing human umbilical cord blood stem cells (HCT/Ps), in accordance with CP 7341.002. The firm processes, stores, and distributes umbilical cord blood stem cells for autologous and allogeneic use in first or second-degree blood relatives, and also processes cord tissue for research. The inspection reviewed quality assurance records, standard operating procedures, equipment maintenance, temperature monitoring, and donor eligibility documentation, among other areas. Although no formal FDA Form 483 (Inspectional Observations) was issued, the inspection identified two verbal observations requiring corrective action. First, a sterilization run record from August 2016 showed an unsatisfactory incubation temperature for a biological indicator without any documented corrective action or re-sterilization of the equipment. Second, Environmental Services Maintenance Reports indicated that the same cleaning solution was used for two consecutive months (August and September 2016), which violated the firm's Sanitization SOP requiring rotation of different cleaning solutions. Mr. Mark L. Portnoy, Co-CEO, acknowledged these observations and committed to implementing the necessary corrections. The firm remains registered with the FDA as required.