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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, [...]

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Blood & Tissue Products FDA Compliance & Registration – XPRO AMERICA

The FDA regulates blood and tissue products to protect public health and ensure safety, efficacy, and quality. Facilities such as blood banks, cord blood banks, and tissue establishments must comply with rigorous regulatory requirements, including registration, donor eligibility screening, labeling, and traceability documentation. At XPRO AMERICA, we provide comprehensive support [...]

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