FDA 483 - Miguelangelo J. Perez-Cruet, M.D., M.S. - December 02, 2009

This FDA Form 483 report details significant deficiencies at Miguelangelo J. Perez-Cruet, M.D., M.S., a clinical investigator in Royal Oak, MI. The inspection revealed widespread issues across multiple studies, including failures in obtaining proper informed consent, inadequate reporting of adverse device effects, and non-compliance with financial disclosure requirements. The firm also failed to conduct investigations according to agreements and protocols, maintained inaccurate and incomplete subject records, and conducted a treatment use study without full IRB approval.