Accreditation Statistics

As of August 1, 2022

Cellular Therapy Entities

  • Accredited: 250
  • Applicants: 25

Cord Blood Banks

  • Accredited: 56
  • Applicants: 7

Congratulations to the following program for achieving initial FACT accreditation: King Abdulaziz Medical City - Riyadh, Saudi Arabia (adult and pediatric allogeneic and autologous hematopoietic progenitor cellular therapy; marrow and peripheral blood cellular therapy product collection; cellular therapy product processing with minimal manipulation). A complete list of accredited organizations can be found at www.factwebsite.org.

Exceptional Release for Investigational Cellular Therapy Products in the U.S.

Posted in :: 2018 Volume 1 :: Thursday, February 15th, 2018

FACT Standard D11.1.2* and its substandards require cellular therapy products to meet pre-determined release criteria prior to distribution from the Processing Facility. When products do not meet release criteria, the Processing Facility Director or Medical Director, as appropriate, must give specific authorization for release.

In the case of investigational products regulated by the Food and Drug Administration (FDA) under Investigational New Drug (IND) applications, the FDA expects that products will not be administered if they fail to meet the release criteria listed in the IND. The FDA recognizes that there are situations when administration of a failed lot may be in the best interest of the patient, but the FDA must be involved in the decision to administer the product. To comply with the FACT Standards, both D11.1.2 and the regulatory requirements of the FDA must be met.

*In the FACT-JACIE Hematopoietic Cell Therapy Standards, the FACT Immune Effector Cell Standards, and the FACT Common Standards.