FDA 483 - Stefan W. Kreuzer, MD - August 13, 2019

An FDA inspection of Stefan W. Kreuzer, MD, an Orthopedic Research Clinic in Houston, TX, revealed a significant issue regarding the conduct of a clinical investigation. The firm failed to adhere to a signed investigational agreement and applicable FDA regulations by not providing accurate and updated financial information to the sponsor, leading to an undeclared conflict of financial interest. This indicates a serious lapse in regulatory compliance concerning financial disclosures in clinical trials.