FDA 483 - Peter Gottlieb, MD - January 11, 2021

An FDA inspection of Peter Gottlieb, MD, a Clinical Investigator in Aurora, CO, revealed significant deficiencies in the conduct of clinical investigations. Observations included failure to adhere to the investigational plan, lack of proper approvals for medical procedures, and inadequate oversight of study staff. The firm also failed to maintain accurate and complete case histories, with issues such as missing lab data and incorrect dating of lab reviews.