FDA 483 - Susan P. King-Harris, D.P.M. - May 09, 2019

An FDA inspection of Susan P. King-Harris, D.P.M. in Farmington Hills, MI, revealed significant non-compliance in the conduct of an investigational new drug (IND) trial. The firm failed to adequately monitor the trial, adhere to the investigational plan regarding subject eligibility and drug administration, and obtain proper Institutional Review Board approvals for study changes. Additional violations included failure to secure informed consent, maintain adequate drug disposition records and case histories, and obtain required FDA-1572 forms from investigators.