MINNEAPOLIS – The tension between device makers and the FDA over how inspections are handled is nothing new, but what may be new is that those tensions seem to have eased little over the past couple of years. Michael Silvestri of Terumo Americas Holding, of Somerset, N.J., said a common industry complaint about the agency's field investigators include is they sometimes show up late for a day's inspectional activity, while at other times the FDAer doesn't show up at all. Read More
