FDA Accredited Persons (AP) Inspection Program
The Accredited Persons (AP) Inspection Program allows a recognized third party, such as Intertek, to perform the equivalent of an FDA Quality System inspection and submit the findings to the FDA for final determination.
Participation in the AP Inspection Program is voluntary - manufacturers may request to use an AP, or continue to go directly through the FDA. To qualify to use an AP, your organization must meet certain criteria set by the FDA.
Using Intertek as your AP Inspection Program provider has many added benefits. By using the same local Intertek auditors that perform your other management systems audits, you'll significantly reduce travel time and expense while being assessed by someone who already knows you. You'll also gain better control over the timing of the inspections, and can even combine them with other audits for additional savings of time and money.
With Intertek performing your quality system assessment, you'll get more than a findings report. You'll have increased confidence in your QMS, and be assured of its conformance to 21 CFR Part 820.
Request more information to see how Intertek can help your organization with FDA Accredited Persons (AP) Inspection Program.