FDA 483 - John Hays - March 22, 2019

This FDA Form 483 was issued to John L. Hays, a Clinical Investigator in Columbus, OH, following an inspection from February 26 to March 22, 2019. The inspection revealed significant deficiencies in the conduct of clinical trials, including failure to adhere to investigational plans, obtain proper informed consent, and promptly report serious adverse events. These issues indicate a lack of control over critical aspects of human subject protection and study integrity.