accreditation statistics

As of April 1, 2021

Cellular Therapy Entities

  • Accredited: 237
  • Applicants: 21

Cord Blood Banks

  • Accredited: 58
  • Applicants: 8

A complete list of accredited organizations can be found at www.factwebsite.org.

Congratulations to the following organization for achieving its initial FACT accreditation:

GW Cancer Center Stem Cell Transplantation and Cellular Therapy Program, Washington, DC

Director: John Barrett, MD

Adult Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation

FDA Publishes Final Guidance for Reporting HCT/P Deviations

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

The Food and Drug Administration (FDA) announced the availability of a final document entitled, “Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Guidance for Industry.”

The guidance document provides certain establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act (PHS Act) and under FDA regulations, with recommendations and relevant examples for complying with the requirements to report HCT/P deviations.