Pub. L. 112-144, tit. VII, sec. 706 (as amended)
RECORDS FOR INSPECTION.
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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