FDA EIR - Douglas R Schumacher MD - May 28, 2014

An FDA inspection was conducted at Douglas R Schumacher MD, located at Radiant Research Columbus, from May 20-28, 2014. The inspection was a targeted review of Dr. Schumacher's conduct as a Clinical Investigator for a Phase III-Pivotal study titled "A multi-centre, Parallel, Double-Blind, Blinded Evaluator, Randomized, Placebo Controlled Study to Evaluate the Safety and Efficacy of a New Viscoelastic Hydrogel (HYMOVIS) in the Treatment of Knee Osteoarthritis with an Open Label Extension," sponsored by Fidia Farmaceutici S.p.A. This clinical trial was covered under Investigational Device Exemption (IDE) G100153. The inspection was performed in accordance with Compliance Program 7348.811, which governs Clinical Investigators and Sponsor-Investigators. During the review, the team assessed various aspects of the study, including protocol adherence, subject records, informed consent processes, and institutional review board communications. Prior items from a previous inspection in 2012, which were discussed but not cited, were verified as corrected. Crucially, the inspection concluded without any significant deficiencies being identified. As a result, no FDA Form 483, which lists inspectional observations, was issued to Douglas R Schumacher MD. This outcome indicates a high level of compliance with regulatory requirements. Consequently, no specific corrective actions were required from the company following this inspection.