roblems Still Abound For FDA's Accredited Persons Inspection Program

摘要

Out-of-pocket fees for device manufacturers, industry apathy and the inability of third-party auditing firms to get investigators certified by FDA are roadblocks that continue to plague the agency's accredited persons (AP) inspection program."It would be very helpful if industry really embraced the program, but the bottom line is that industry is not embracing it," David Kalins, CDRH's AP program coordinator, told "The Silver Sheet."