FDA 483 - Wayne G. Shreffler, M.D. - January 31, 2020

An FDA inspection of Wayne G. Shreffler, M.D. in Boston, MA, a clinical investigator, revealed one observation related to the conduct of a clinical investigation. The firm failed to conduct an investigation in accordance with the investigational plan, specifically regarding the allocation of study materials to subjects. This indicates a deviation from established study protocols and training materials.