FDA issues guidance for refused inspections
Guidance explains how FDA interprets refusals of entry for inspection
The FDA has issued guidance for how it interprets refusals of entry for inspection for foreign food facilities as well as foreign governments.
The FDA’s Import Alert 99-32 has a red list of foreign establishments of which the owner, operator, agent in charge or foreign government has refused an inspection. Food offered from these establishments is subject to refusal of admission.
In the cases of government refusals, establishments will be added to the red list on a case-by-case basis, but if refusals are sustained, FDA will ask the foreign government if refusal applies to all establishments in the country. If so, all establishments in the country will be added to the red list.