Sec. 5. Records for or in lieu of certain inspections
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Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(a)(4) ) is amended— by redesignating subparagraphs
(B)through
(D)as subparagraphs
(C)through (E), respectively; by inserting after subparagraph
(A)the following new subparagraph: Any records or other information that the Secretary may remotely inspect or copy under authority of this Act from a person that owns or operates, or is an agent in charge of, an establishment that is engaged in any of the activities described in clause
(ii)shall, upon the request of the Secretary, be provided to the Secretary by such person, in advance of, at the time of, or in the case in which an in-person inspection would be unsafe, in lieu of, an in-person, on-site inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such person. The Secretary’s request shall include a sufficient description of the records or other information requested. The activities described in this clause are records relating to— the manufacturing, processing, sampling, testing, packing, transporting, distributing, receiving, holding, or importing of an article of food; or the distribution or use of animal feed bearing or containing a veterinary feed directive drug, or the issuance of a veterinary feed directive. ; and by adding at the end the following: Section 703 does not apply to records obtained or copied, or other information obtained or copied pursuant to a request made under this section. .
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Sec. 5
Records for or in lieu of certain inspections
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