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 for organizations handling blood and tissue products, ensuring full compliance with FDA regulations while minimizing risk and streamlining operations.

Key Services:

• Registration for Blood Banks & Tissue Establishments: All facilities collecting, processing, storing, or distributing blood and tissue products must register with the FDA. XPRO AMERICA manages accurate facility registration and product listings, ensuring timely compliance.
• Donor Eligibility & Screening Compliance: FDA mandates strict donor eligibility criteria, testing, and screening protocols. We help implement and document compliant procedures to protect patient safety and meet regulatory standards.
• Labeling & Traceability Documentation: Accurate labeling and traceability are essential for all blood and tissue products. Our team reviews labeling, lot tracking, and documentation systems to ensure compliance with FDA requirements and facilitate effective product recalls if necessary.
• Regulatory Strategy & Ongoing Support: XPRO AMERICA provides guidance on inspections, post-market reporting, and updates to FDA regulations, helping facilities maintain continuous compliance and operational readiness.

Why Choose XPRO AMERICA?

• Expertise in FDA regulations for blood and tissue products.
• End-to-end support from registration to donor compliance and traceability.
• Preparation for FDA inspections and audits.
• Minimizes regulatory risk while ensuring safe and compliant product handling.

Partnering with XPRO AMERICA allows blood banks and tissue establishments to confidently meet FDA regulatory obligations. Our services ensure that facilities maintain proper registration, donor screening, labeling, and traceability, providing regulatory assurance and safeguarding public health while enabling smooth operations and market access.

XPRO AMERICA ensures FDA compliance for blood banks and tissue establishments with registration, donor screening, labeling, and traceability support.