FDA EIR - Banco Vida Corp. - July 01, 2016

An FDA inspection of Banco Vida Corp., a human tissue establishment specializing in umbilical cord blood processing and storage services, was conducted from June 29 to July 1, 2016. Located in San Juan, Puerto Rico, the firm processes and cryopreserves stem cells derived from umbilical cord blood for autologous or closely related allogeneic use. The comprehensive inspection was performed under Compliance Program 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), and is regulated by 21 CFR 1270, 1271, and the PHS Act. The inspection covered critical areas such as facilities, employee practices, equipment maintenance and calibration, training, record-keeping, material storage, donor eligibility, informed consent, and quality assurance. Notably, the inspection concluded without any serious deviations from current Good Tissue Practices, and no Form FDA-483, Inspectional Observations, was issued. The firm had no registered consumer complaints, biological product deviation reports, or product recalls. No specific regulatory actions were required as a direct result of this inspection, indicating a satisfactory state of compliance.