FDA 483 - Miguelangelo J. Perez-Cruet, M.D., M.S. - August 25, 2023

An FDA inspection of Miguelangelo J Perez-Cruet, M.D., M.S. in Waterford Township, MI, revealed significant deficiencies in the conduct of a clinical investigation, Protocol LSS17001. The firm failed to obtain proper informed consent, ensure adequate principal investigator oversight, maintain accurate subject records, manage protocol deviations, and provide accurate information to the Institutional Review Board. These issues indicate a serious lack of adherence to regulations governing human subject protection and clinical trial conduct.