Sec. 705. RISK-BASED INSPECTION FREQUENCY
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## SEC. 705 RISK-BASED INSPECTION FREQUENCY Section 510(h) (21 U.S.C. 360(h)) is amended to read as follows: > > ### “(h) Inspections > > > #### “(1) In general > > Every establishment that is required to be registered with the Secretary under this section shall be subject to inspection pursuant to section 704. > > > #### “(2) Biennial inspections for devices > > Every establishment described in paragraph (1), in any State, that is engaged in the manufacture, propagation, compounding, or processing of a device or devices classified in class II or III shall be so inspected by one or more officers or employees duly designated by the Secretary, or by persons accredited to conduct inspections under section 704(g), at least once in the 2-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive 2-year period thereafter. > > > #### “(3) Risk-based schedule for drugs > > The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect establishments described in paragraph
(1)that are engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs (referred to in this subsection as ‘drug establishments’) in accordance with a risk-based schedule established by the Secretary. > > > #### “(4) Risk factors > > In establishing the risk-based scheduled under paragraph (3), the Secretary shall inspect establishments according to the known safety risks of such establishments, which shall be based on the following factors: > > > ##### “(A) > > The compliance history of the establishment. > > > ##### “(B) > > The record, history, and nature of recalls linked to the establishment. > > > ##### “(C) > > The inherent risk of the drug manufactured, prepared, propagated, compounded, or processed at the establishment. > > > ##### “(D) > > The inspection frequency and history of the establishment, including whether the establishment has been inspected pursuant to section 704 within the last 4 years. > > > ##### “(E) > > Whether the establishment has been inspected by a foreign government or an agency of a foreign government recognized under section 809. > > > ##### “(F) > > Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources. > > > #### “(5) Effect of status > > In determining the risk associated with an establishment for purposes of establishing a risk-based schedule under paragraph (3), the Secretary shall not consider whether the drugs manufactured, prepared, propagated, compounded, or processed by such establishment are drugs described in section 503(b). > > > #### “(6) Annual report on inspections of establishments > > Beginning in 2014, not later than February 1 of each year, the Secretary shall make available on the Internet Web site of the Food and Drug Administration a report regarding— > > > ##### “(A) > > > ######
(i)> > the number of domestic and foreign establishments registered pursuant to this section in the previous fiscal year; and > > > ###### “(ii) > > the number of such domestic establishments and the number of such foreign establishments that the Secretary inspected in the previous fiscal year; > > > ##### “(B) > > with respect to establishments that manufacture, prepare, propagate, compound, or process an active ingredient of a drug, a finished drug product, or an excipient of a drug, the number of each such type of establishment; and > > > ##### “(C) > > the percentage of the budget of the Food and Drug Administration used to fund the inspections described under subparagraph (A).” > .
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Sec. 705
RISK-BASED INSPECTION FREQUENCY
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