The American Association of Tissue Banks (AATB) sets standards, inspects facilities, and accredits tissue banks in North America. Alamo Biologics has been accredited by the AATB since 1999 and is a respected member and participant.
The Food and Drug Administration (FDA)’s 21 CFR 1271 regulations apply to all U.S. tissue banks and their affiliates. These regulations outline criteria for tissue donor selection, and they authorize the FDA to inspect human tissue bank facilities that recover, process, or distribute tissue grafts for transplant. The FDA mandates registration and good tissue practices within the new regulations. Alamo Tissue Services is registered with the FDA and is in full compliance with their regulations.
Alamo Biologics adheres to strict written policies and standard operating procedures in all activities. Our policies and procedures are routinely updated to remain current with all applicable standards and regulations. Quality assurance audits are routinely performed on all internal and external processes.