Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government


How To Comment

Submit either electronic or written comments on the draft guidance by February 26, 2018 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.

Submit electronic comments on to docket number FDA-2017-D-6528.

Submit written comments to:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2017-D-6528.


For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition at 240-701-5986, or the Center for Veterinary Medicine at 240-402-7001, or the Office of Regulatory Affairs at 202-402-4565.

Contains Nonbinding Recommendations
Draft - Not for Implementation

December 2017

This guidance is being distributed for comment purposes only.

This guidance provides information for foreign food facilities subject to our inspection as well as foreign governments on how we interpret “refuses to permit entry … to inspect” a foreign food establishment, pursuant to section 807(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384c(b)). The examples used in this guidance are not intended to serve as an exhaustive list. Rather, they illustrate situations that we may encounter in preparing for and conducting inspections.  

Terms used in this guidance include:

  • The term “U.S.” refers to the United States. 
  • The pronouns “we” and “our” refer to FDA. 
  • The term “food” means: (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.  (Section 201(f) of the FD&C Act (21 U.S.C. 321(f)).  
  • The term “foreign food establishment” or “establishment” is used in this guidance to refer to a foreign factory, warehouse, or other establishment that manufactures, processes, packs, or holds, food.  “Establishments” as used in this guidance include farms (as defined in 21 CFR 1.227 and 112.3).
  • The term “owner, operator, or agent in charge” is used in this guidance to refer to the owner, operator, or agent in charge of the foreign food establishment, or an individual authorized by the owner, operator, or agent in charge of the foreign food establishment, to be the contact person for the purposes of our inspection.
  • The term, “FDA investigators” refers to “United States inspectors or other individuals duly designated by the Secretary.”  (Sec. 807(b) of the FD&C Act (21 U.S.C. 384c(b))
  • The term, “foreign governments” refers to foreign governments and competent authorities of foreign countries.

Our guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

Download the Draft Guidance for Industry 
(PDF: 84KB )

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