FDA EIR - Jeffrey Mitchell Weinberg, MD - April 23, 2018

An FDA inspection of Jeffrey Mitchell Weinberg, MD, operating as Forest Hills Dermatology Group, was conducted from April 19-23, 2018. This clinical investigator inspection, performed under Compliance Program 7348.811, focused on protocol GP17-301, a biosimilar adalimumab study sponsored by Sandoz Inc. The inspection identified several deficiencies, resulting in the issuance of an FDA Form 483, Inspectional Observations. Main violations included the investigation not being conducted in accordance with the investigational plan, specifically regarding subject re-screening procedures (a required serum pregnancy test was not repeated) and a subject not being on a stable dose of concomitant medication for the protocol-specified duration prior to study treatment. Additionally, the inspection found a failure to prepare or maintain adequate and accurate case histories, evidenced by unrecorded concomitant medications in electronic case report forms (eCRFs) and the incorrect stratification of several subjects at randomization. A verbal discrepancy was also discussed, noting subjects were enrolled and treated despite showing signs of hypertension, with the sponsor’s interpretation of exclusion criteria differing from standard practice. As required actions, Dr. Weinberg indicated he would consult with the study sponsor regarding providing a written response to the FDA’s observations within 15 business days.