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Problems Still Abound For FDA's Accredited Persons Inspection Program

This article was originally published in The Silver Sheet

Executive Summary

FDA'S ACCREDITED PERSONS (AP) INSPECTION PROGRAM IS STRUGGLING because of financial costs to manufacturers, difficulties in getting third-party auditors trained and industry apathy, experts say. Since it was created in 2003, only about 90 inspections have been completed under the program, which allows manufacturers to hire agency-approved auditors to conduct FDA quality system inspections. "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 says. Two of the 16 auditing firms certified by the agency to perform AP inspections - Underwriters Laboratories and TUV SÜD America - talk about the challenges they face. Meanwhile, an updated FDA guidance on the AP program explains statutory changes made in 2007 that make it easier for firms to take part

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