Background

The Food and Drug Administration is accepting comments through Feb. 27 on a draft guidance document outlining what type of actions by a foreign food establishment or foreign government would constitute a refusal of FDA inspection.

Under the Food Safety Modernization Act, the FDA must refuse admission of a food into the U.S. if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of U.S. inspectors to inspect the facility. In addition, the Federal Food, Drug, and Cosmetic Act states that owners, operators, or agents in charge are considered to have refused an inspection if they do not permit it within 24 hours of an FDA request (or such other time period as may be mutually agreed).

The draft guidance states that refusing to permit an inspection or the entry of inspectors includes statements, actions, and passive behaviors that prevent or delay the FDA from scheduling or fully conducting an inspection. Refusal also includes statements, actions, and passive behaviors intended to avoid inspection or to mislead or deceive the FDA investigator. Minor delays that result from good faith efforts by the establishment to comply with FDA requests generally would not be considered a refusal of inspection.

See the draft guidance, attached, for more information.

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