FDA 483 - Institute of Regenerative and Cellular Medicine - October 19, 2021

An FDA inspection of the Institute of Regenerative and Cellular Medicine in Santa Monica, CA, revealed significant deficiencies in its Institutional Review Board (IRB) operations. The firm failed to maintain complete records of continuing review activities, did not follow its own written procedures for informing Principal Investigators (PIs) of IRB actions, and lacked sufficiently detailed meeting minutes for controverted issues and resolutions. Furthermore, the IRB reviewed drug studies for which it was not registered, indicating a systemic failure in regulatory compliance and oversight of clinical trials.