On December 11, 2017, FDA issued a draft guidance explaining when the Agency considers a foreign food establishment's or foreign government's action to be a refusal to permit entry to inspect a food facility. In the guidance, FDA states that not only actions but statements and passive behaviors that prevent or delay FDA investigators from scheduling or fully conducting an inspection, or that are intended to avoid inspection or to mislead or deceive would be considered a refusal to inspect. For example, FDA would so classify not responding within 24 hours after FDA issues a written inspection request. Similarly, FDA could make such a finding when the owner, operator, or agent in charge of a facility stops communicating with FDA at any time after he or she initially responds to FDA's request to schedule an inspection, provides an incomplete or inaccurate response (e.g., an owner, operator, or agent in charge falsely claims the establishment is not operating or does not ship food to the United States), rejects (without a reasonable explanation) FDA's attempt to schedule an inspection by not agreeing to an inspection start date, or agrees to an inspection start date and then requests a later date without giving a reasonable explanation. Other examples are when FDA is directly prevented from entering the establishment, is barred from entering a specific area, is asked to not take photographs or collect samples for analysis, or when a foreign government bars access to the country.
Under FSMA, to ensure the imported products meet U.S. standards and are safe for consumers, FDA can deny entry of food products if the Agency has been prevented from inspecting the facility where such products have been manufactured, processed, packed, or held. If FDA is denied entry to a foreign food establishment—either by the facility or the foreign government—FDA will place the food establishment(s) on the Red List of "Import Alert 99-32 Detention Without Physical Examination of Products From Firms Refusing FDA Foreign Establishment Inspection," and food products will not be able to enter into the United States.
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