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Code · STATUTE-COMPILATIONS · Food and Drug Administration Safety and Innovation Act · Sec. 706

Sec. 706. RECORDS FOR INSPECTION

189 words·~1 min read·/statute-compilations/comps-9932/sec-706

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## SEC. 706 RECORDS FOR INSPECTION Section 704(a) (21 U.S.C. 374(a)) is amended by adding at the end the following: > > #### “(4) > > > #####
(A)> > Any records or other information that the Secretary may inspect under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug shall, upon the request of the Secretary, be provided to the Secretary by such person, in advance of or in lieu of an 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 requested. > > > ##### “(B) > > Upon receipt of the records requested under subparagraph (A), the Secretary shall provide to the person confirmation of receipt. > > > ##### “(C) > > Nothing in this paragraph supplants the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance with this Act.” > .
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Sec. 706
RECORDS FOR INSPECTION
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