Demand for cell therapy accreditation is growing faster than the pool of volunteers who conduct inspections, according to a study published Nov. 10 in Blood Advances.
Researchers from the Foundation for the Accreditation of Cellular Therapy analyzed accreditation records and inspection results to assess the workload of volunteer inspectors and whether programs with inspectors on staff received fewer citations.
Here are five notes from the study:
- As of June 2026, FACT had 263 volunteer inspectors to review 342 accredited cell therapy programs and cord blood banks, along with 43 new applications.
Between 2016 and 2025, FACT granted 178 accreditations for immune effector cell therapies, such as CAR-T.
Initial inspections totaled 26 in 2025, compared with 11 in 2023 and eight in 2024. - Of the 207 accredited cell therapy programs inspected between 2018 and 2022, 64% had no staff members serving as FACT inspectors at the time of inspection.
- Programs that employed at least one inspector averaged 9.7 citations per inspection, compared with 13.1 at programs with none. Programs with two inspectors averaged 6.8 citations while those with three averaged 5.4.
- Experienced inspectors estimated each inspection took an average of 26.5 hours of direct work and required roughly two to three days away from their regular jobs.
- In 2023, 43% of active inspectors completed two or more inspections, meeting FACT’s expectation of two inspections a year.
Read the full study here.
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