FDA 483 - Kenneth B. Strenge, MD - May 16, 2024

An FDA inspection of Kenneth B. Strenge, MD in Paducah, KY, a clinical investigator, revealed a significant deviation from an investigational plan. The firm failed to conduct a clinical study according to its protocol by enrolling two subjects who met exclusionary criteria for an investigational device study. This indicates a failure to adhere to established study guidelines and subject eligibility requirements.