Compliance Monitoring

Revelation Wellness is committed to patient safety and product integrity are at the core of everything we do. We maintain the highest standards of regulatory compliance and quality control to ensure every product is safe, ethical, and effective.

• AATB Accredited
  We are proudly accredited by the American Association of Tissue Banks (AATB), a distinction that reflects our commitment to ethical sourcing, safe tissue handling, and industry-leading protocols.
• cGMP Compliant Facility
  Our lab follows Current Good Manufacturing Practices (cGMP), meeting FDA standards for cleanliness, sterility, documentation, and process control to ensure consistent product quality.
• FDA Registered
  Our lab is registered with the FDA for human cell and tissue products (HCT/Ps) under 21 CFR Part 1271, ensuring compliance with federal safety regulations.
• Rigorous Donor Screening
  All donor tissue is sourced from non-compensated, U.S.-based donors and undergoes thorough eligibility screening, including infectious disease testing and behavioral risk assessment per FDA and AATB guidelines.
• End-to-End Traceability
  Every product is tracked from donor intake through processing to final delivery. We retain and audit batch records to ensure full transparency and accountability.
• Sterility & Environmental Testing
  Each lot undergoes validated sterility testing. Our cleanrooms are closely monitored to maintain strict environmental control and product safety.