VITTI LABS Information

Regulations: Vitti Labs implements and maintains quality and regulatory assurance in alignment with FDA regulations. We do so by building strict protocols and processing to uphold these requirements. In addition we perform FDA mock audits three times a year. We also implement the American Association of Tissue Banking standards, follow GMP guidelines, Good Tissue Practices, and World Health Organization requirements. Sourcing: Vitti Labs only accepts bio-ethically donated birth tissue from healthy consenting mothers in the United States who have passed a comprehensive medical background check, blood screenings, and have full-term, live, C-section births. I n addition, we only work with tissue procurement organizations within the United States who use collection techniques that follow the AATB guidelines, prioritizing the health and safety of the mother and baby above procurement. We do this to have a 100% FDA and AATB compliant supply chain, validated sterility, and the highest quality procurement. Testing + Validation: 20% of every lot manufactured is sent for sterility and endotoxin testing by a 3rd party laboratory. Testing Guidelines