FDA 483 - Stefan W. Kreuzer, MD - August 13, 2019
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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.
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ID · c53fcd9c-d4b4-4e2e-9ff5-3d9c6ed27b00