Import Alert 99-32: Detention without physical examination of human and animal food products from foreign establishments refusing FDA inspection

The refusal to permit inspection of a foreign facility or provide reasonable access to FDA's inspection personnel, combined with other evidence, establishes an appearance that the firm's products are manufactured, processed, or packed under insanitary conditions.

The Red List of this import alert identifies firms that have offered FDA-regulated articles for import into the United States and failed to respond to FDA’s official notification of potential inspection and/or refused to allow the completion of an FDA inspection of their foreign establishment for the purpose of determining establishment conditions and compliance with applicable laws and regulations, for example compliance with FDA's Low-Acid Canned Food regulation, 21 CFR part 113. On the basis of a refusal from a firm listed on the Red List, combined with other evidence, it appears that their articles were manufactured, processed, or packed under insanitary conditions for purposes of section 801(a)(1) of the FD&C Act. Therefore, such articles are subject to refusal of admission into the US.

Section 807 of the FD&C Act (21 U.S.C. 384c(b)), provides FDA with the authority to refuse admission of food into the United States 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 United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment. For the purposes of this charge, such an owner, operator, or agent in charge shall be considered to have refused an inspection if such owner, operator, or agent in charge does not permit an inspection of a factory, warehouse, or other establishment during the 24-hour period after such request is submitted, or after such time period, as agreed upon by FDA and the foreign factory, warehouse, or other establishment.

Foreign factories, warehouses, or other establishments who refuse to permit entry of United States inspectors or other individuals, duly designated by the Secretary, to inspect their factories, warehouses, or other establishments will be listed on the Red List of this import alert, food products from those facilities are subject to refusal of admission as set forth in section 807 of the FD&C Act.

Note: As of October 28, 2021, drug firms previously added to the Red List for this Import Alert are now covered under Import Alert 66-79, "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection."