The Accredited Persons (AP) Inspection Program allows for accredited persons to conduct the equivalent of an FDA quality system audit for manufacturers of FDA-regulated products. The accreditation is granted to third parties based on certain eligibility criteria and training. Manufacturers can opt for an accredited third party to inspect their facility when they meet the eligibility criteria...

1. Accredited Persons (AP) Inspection Program
By: Nikita Angane
The Accredited Persons (AP) Inspection Program allows for accredited persons to
conduct the equivalent of an FDA quality system audit for manufacturers of FDA-regulated
products. The accreditation is granted to third parties based on certain eligibility criteria and
training. Manufacturers can opt for an accredited third party to inspect their facility when they
meet the eligibility criteria.1
In order to avoid conflict of interests and maintain the integrity of this program, there
are certain eligibility requirements to be an accredited person to conduct FDA inspections. Some
of them are: 1
 Qualifications for AP personnel will be equivalent to that of FDA personnel.
 FDA retains responsibility for making the final compliance decision of the
inspection.
 FDA conducts onsite visits periodically to each AP to audit performance and
inspect records, correspondence, and other materials relating to the inspection
under the AP program
 FDA will monitor and evaluate each AP’s independence and compliance with the
act.
FDA pays special attention to ensure that the parties seeking accreditation are free from
any commercial or financial pressures to effectively carry out an impartial audit.1
For manufacturers, the eligibility to be inspected by an accredited person is primarily
based on the firm’s compliance history and whose most recent inspection by the FDA was
classified as either “No Action Indicated (NAI)” or “Voluntary Action Indicated (VAI)”.1
The AP program is similar to how the EU Commission relies on accredited third-party
entities such as notified bodies to conduct competency assessments and regulatory duties. It
would be interesting to see how this program flourishes in the future and companies respond to
this process. So far, FDA has been using APs for the last 5 years and has completed about 90
FDA inspections through accredited third parties.1
Need help with pre-inspection prep? Call us today at 248-987-4497 or email us at
info@emmainternational.com to learn more about how we can help!

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1 FDA (Aug 2020) Accredited Persons Inspection Program – Guidanceretrieved on 03/30/2021 from
https://www.fda.gov/media/73458/download