What is the Inspection by Accredited Persons (AP) Program?
The program permits APs to perform the equivalent of an FDA QS inspection and to submit the findings to FDA for final inspectional classification. In accordance with the requirements of section 704(g) of the act, (21 U.S.C. 374(g)), an inspection under the AP program includes features designed to maintain a high level of confidence in inspections conducted by APs and to minimize risks to the public health. These features include the following: • Eligibility for inspection by APs is primarily limited to establishments whose most recent inspection was classified by FDA as either “No Action Indicated (NAI)” or “Voluntary Action Indicated (VAI)” (704(g)(6)(A)(i)) (21 U.S.C. 347(g)(6)(A)(i)); • Assessment, accreditation, and training of APs by FDA will occur before APs conduct independent inspections; APs will not be eligible to conduct independent inspections until they successfully complete FDA’s training program and perform a satisfactory inspection under FDA’s observation (704(g)(2)) (2
