Inspections, Compliance, Enforcement, and Criminal Investigations


Section 702(a)(1)(A) of the Act authorizes FDA "to conduct examinations and investigations for the purposes of this Act…through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary as an officer of the Department."

Section 702(a)(2) of the Act, as amended by the BT Act, authorizes FDA, pursuant to a memorandum of understanding, to "conduct examinations and investigations for the purposes of the Act through the officers and employees" of other Federal departments and agencies. Under this provision, FDA may commission other Federal officials pursuant to a memorandum of understanding between the Secretary and the head of the other Federal department or agency. Such a memorandum of understanding is only effective in the case of examinations or inspections at facilities or other locations that are "jointly regulated" by FDA and the other Federal agency or department.

Page Last Updated: 05/02/2016
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