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

An FDA inspection conducted from January 27-31, 2020, at Wayne G. Shreffler, M.D., Massachusetts General Hospital, resulted in the issuance of an FDA Form 483. The inspection identified a significant observation concerning the conduct of a clinical investigation. The primary issue was that the study was not conducted in accordance with its established investigational plan. Specifically, study staff did not consistently adhere to the procedures outlined in Investigator Meeting and Site Initiation Visit training materials regarding the allocation of investigational materials to subjects. Instances were noted where allocated materials differed from those actually used, and in another case, material was prepared for a subject without proper formal allocation. This observation highlights a deviation from regulatory expectations for the proper conduct of clinical investigations, as stipulated by the Federal Food, Drug, and Cosmetic Act. The firm is expected to thoroughly review these findings and implement robust corrective and preventative actions to ensure full compliance with study protocols and regulatory requirements in future research activities.