§384e. Recognition of foreign government inspections — Inbound Citations

Citations to 21 U.S.C. § 384e as a whole

• 21 U.S.C. § 360(h)(4)(E)

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  (E) Whether the establishment has been inspected by a foreign government or an agency of a foreign government recognized under section 384e of this title.
• 21 U.S.C. § 360(h)(6)(A)(vii)

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  (vii) the number of inspections the Secretary has recognized pursuant to an agreement entered into pursuant to section 384e of this title, or otherwise recognized, for each of the types of inspections described in clauses (v) and (vi), including for inspections of establishments in each region of interest.²
• 21 U.S.C. § 360(h)(6)(D)

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  (D) the status of the efforts of the Food and Drug Administration to expand its recognition of inspections conducted or recognized by foreign regulatory authorities under section 384e of this title, including any obstacles to expanding the use of such recognition.
• 21 U.S.C. § 381(r)(3)(B)

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  (B) through representation by a foreign government or an agency of a foreign government recognized under section 384e of this title; or