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, we provide specialized regulatory guidance and support for HCT/P companies, ensuring compliance with FDA standards while minimizing risk and streamlining operations.

Key Services:

• Registration & Listing under 21 CFR Part 1271: All domestic and foreign HCT/P facilities must register with the FDA and list each HCT/P product. XPRO AMERICA manages the registration process, ensuring timely and accurate submission of facility and product information.
• Compliance with Good Tissue Practices (GTP): GTP requirements cover donor eligibility, tissue handling, processing, storage, and distribution. We assist clients in implementing procedures, maintaining documentation, and ensuring consistent adherence to regulatory standards.
• FDA Inspection Readiness: FDA inspections of HCT/P facilities assess compliance with Part 1271 and GTP requirements. XPRO AMERICA conducts mock audits, gap analyses, and CAPA planning, preparing your organization for successful FDA inspections.
• Labeling & Traceability Support: Accurate labeling, documentation, and tracking of HCT/Ps are critical for safety and regulatory compliance. We review systems and procedures to maintain traceability and ensure adherence to FDA expectations.

Why Choose XPRO AMERICA?

• Deep expertise in HCT/P regulations and Good Tissue Practices.
• End-to-end support from registration and product listing to inspection readiness.
• Structured approach to documentation, donor screening, and CAPA implementation.
• Minimizes compliance risk while ensuring operational efficiency and regulatory assurance.

Partnering with XPRO AMERICA ensures that HCT/P manufacturers, processors, and distributors remain fully compliant with FDA regulations, maintain robust quality systems, and are inspection-ready at all times. Our services provide peace of mind, regulatory assurance, and streamlined operational compliance in a highly regulated sector.

XPRO AMERICA supports HCT/P companies with FDA registration, Good Tissue Practices compliance, and inspection readiness under 21 CFR Part 1271.