FDA 483 - Howard Conter, M.d. - November 29, 2013

MSHJ Research Associates in Halifax, Canada, was cited for deficiencies during a clinical investigation for a type 2 diabetes mellitus study. The inspection revealed that the investigation was not conducted in accordance with the investigational plan, leading to missed follow-ups and undocumented adverse events. Additionally, the firm failed to maintain accurate case histories, with discrepancies found in subject medication dosages and visit dates.