CERTIFICATES & LICENSES

MEETING AND EXCEEDING HUMAN TISSUE BANK STANDARDS

One Biologics is committed to providing high-quality services to its customers. We strictly follow licensing and certification standards to ensure the safety and effectiveness of our products.

Our licenses and certificates ensure that we maintain the industry's highest quality and safety standards. Regulatory agencies such as the FDA and the American Association of Tissue Banks (AATB) conduct stringent evaluations and inspections before granting us these licenses and certificates.

One Biologics' licenses and certificates guarantee safe and quality human tissue acquisition and processing for transplantation.

Food and Drug Adminstration

The regulations named 21 CFR 1271 of the Food and Drug Administration (FDA) are applicable to all tissue banks and their affiliated institutions in the United States. These regulations set forth the criteria for selecting tissue donors and authorize the FDA to scrutinize facilities that recover, process, or distribute tissue grafts for transplants. The FDA mandates registration and compliance with good tissue practices within the new regulations. One Biologics is registered with the FDA and fully adheres to their regulations.

FDA REGISTRATION 2024

American Association of Tissue Banks

The American Association of Tissue Banks (AATB) is responsible for setting standards, inspecting facilities, accrediting tissue banks, and accrediting tissue bank specialists in North America. One Biologics Medical Director has been a respected member, CTBS and participant since 2019.

AATB CTBS CERTIFICATION 2022-2025