FDA 483 - Maggie Jeffries MD - August 05, 2021

An FDA inspection of Maggie Jeffries MD, conducted from July 19 to August 5, 2021, identified several critical violations related to the conduct of clinical investigations. The most significant finding was the firm's failure to submit an Investigational New Drug (IND) application to the FDA prior to initiating a clinical study, which involved treating 611 subjects with an investigational compounded drug. This directly contravenes regulatory requirements for clinical trials involving unapproved drugs.

Further observations revealed serious deficiencies in the informed consent process. The firm failed to provide subjects or their authorized representatives with a complete, signed, and dated copy of the informed consent form at the time of consent, retaining only signature pages. Additionally, many consent forms were not dated by the subjects themselves, but rather by study personnel. The inspection also highlighted inadequate documentation within case histories, specifically lacking proof that informed consent was obtained before any study procedures. Furthermore, the investigator failed to adequately evaluate reported adverse events from approximately 24 subjects, including those receiving the study drug, for safety, relatedness, or severity. These observations indicate substantial non-compliance with regulations governing human subject protection and ethical clinical research. Prompt corrective actions are expected to address these serious deviations.