FDA Pushes for Participation in AP Inspection Program

To help keep up with device inspections, the FDA is recruiting participants for its accredited persons (AP) third-party inspection program for eligible manufacturers of Class II and III devices.

Since the inspection program was implemented in 2003, the FDA has accredited 16 organizations, trained 60 AP auditors and participated in joint inspections and audits with more than 40 AP auditors, the agency says in a new guidance on how to get AP accreditation. A related guidance for manufacturers wanting to participate in the program updates a September 2005 guidance.

The future of the voluntary program was in jeopardy last year because manufacturers were hesitant to participate. Since the beginning of the program, the FDA has had trouble getting manufacturers to sign on, because under the program, manufacturers pay for the AP inspection while the FDA does not charge for its inspection.
The GMP Letter