FDA 483 - Maggie Jeffries MD - August 05, 2021

This FDA Form 483 was issued to Maggie A. Jeffries, M.D., a Sponsor/Investigator in Houston, TX, following an inspection of clinical investigations. The inspection revealed significant deficiencies, including the failure to submit an Investigational New Drug (IND) application prior to conducting a clinical study involving 611 subjects. Additionally, severe issues were noted regarding informed consent documentation, such as not providing complete consent forms to subjects, lack of proper dating by subjects, and inadequate maintenance of case histories, including the failure to evaluate reported adverse events.