FDA EIR - Banco Vida Corp. - December 07, 2017

An FDA inspection of Banco Vida Corp., a human tissue establishment specializing in umbilical cord blood processing and storage services, was conducted from December 6-7, 2017, in San Juan, Puerto Rico. This comprehensive inspection, part of the FY-18 work plan, followed Compliance Program 7341.002, focusing on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) regulations. The firm coordinates the collection of umbilical cord blood products and ensures their transport for processing and storage. The inspection covered critical systems, including registration, donor eligibility, and current good tissue practices. Notably, the report indicated no serious deviations from current Good Tissue Practices (cGTP) regulations. Consequently, no Form FDA-483, Inspectional Observations, was issued, signifying that no objectionable conditions were found. Management was reminded of their ongoing responsibility to ensure compliance with the Food, Drug, and Cosmetic Act and HCT/Ps Regulations. No samples were collected, and no refusals were encountered during the two-day inspection.