Sec. 3613. Improving Food and Drug Administration inspections
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Section 510(h)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(h)(4) ) is amended— by redesignating subparagraph
(F)as subparagraph (G); and by inserting after subparagraph
(E)the following: The compliance history of establishments in the country or region in which the establishment is located that are subject to regulation under this Act, including the history of violations related to products exported from such country or region that are subject to such regulation. . Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(a)(4) ) is amended— by redesignating subparagraph
(C)as subparagraph (D); and by inserting after subparagraph
(B)the following: The Secretary may rely on any records or other information that the Secretary may inspect under this section to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection, or to resolve deficiencies identified during such inspections, if applicable and appropriate. . Section 809 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384e ) is amended— in subsection (a)(1), by inserting preapproval or before risk-based inspections ; and by adding at the end the following: Beginning not later than 1 year after the date of the enactment of the Food and Drug Omnibus Reform Act of 2022, the Secretary shall periodically assess whether additional arrangements and agreements with a foreign government or an agency of a foreign government, as allowed under this section, are appropriate. Beginning not later than 4 years after the date of the enactment of the Food and Drug Omnibus Reform Act of 2022, and every 4 years thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing the findings and conclusions of each review conducted under paragraph (1). .
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