FDA 483 - Christopher J. Hartnick, MD - June 28, 2019

An FDA inspection of Christopher J. Hartnick, MD, a sponsor-investigator in Boston, MA, revealed significant deficiencies in the conduct and oversight of an investigational device study. The firm failed to ensure proper monitoring, maintain accurate and complete subject case histories, and secure essential commitments in clinical trial agreements. Additionally, issues were noted with investigational device record-keeping and labeling.