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HCT/P Regulatory Compliance & FDA Registration – XPRO AMERICA

Human Cells, Tissues, and Cellular/Tissue-Based Products (HCT/Ps) are highly regulated by the FDA to ensure safety, quality, and traceability. Facilities that manufacture, process, store, or distribute HCT/Ps must comply with 21 CFR Part 1271 requirements, including registration, listing, adherence to Good Tissue Practices (GTP), and inspection readiness. At XPRO AMERICA, [...]