On October 20, FDA issued final guidance that describes the actions, behaviors, and statements by a foreign food establishment or foreign government that the FDA considers to be a refusal of an inspection. As our readers may recall, FDA published its draft guidance concerning refusal of inspections back in December 2017.

Food for importation into the United States comes from all over the world.  One way that the FDA protects the U.S. food supply is by conducting inspections of foreign food facilities to identify potential food safety concerns. The Food Safety Modernization Act (FSMA) gives FDA authority to refuse entry of food offered for importation into the United States if the foreign food establishment or foreign government has refused to permit the FDA to inspect the foreign establishment that produced the food. The guidance issued yesterday provides examples of situations that FDA may consider as constituting refusal.

A non-exhaustive list of example situations in which FDA would consider a foreign food establishment to have “refused” an inspection include when an operator, agent, or owner in charge:

• Does not respond to FDA during the 24-hour period after submission by FDA of a written inspection request;

• Stops communicating with FDA at any time after the owner, operator, or agent in charge initially responds to FDA’s request to schedule an inspection;

• Agrees to an inspection start date and then requests a later date without giving a reasonable explanation;

• Refuses to permit entry to the establishment;

• Sends staff home for the day, without a reasonable explanation, and tells the FDA investigator that the establishment is not producing any product;

• Does not answer telephone calls from the FDA investigator who is present at the establishment and unable to gain entry to the establishment;

• Bars the FDA investigator from an area of the establishment where food is grown, harvested, manufactured, processed, prepared, packed, or held;

• States that direct observation of an establishment, in whole or in part, must be limited to an unreasonably short amount of time;

• Makes statements, actions, and passive behaviors intended to avoid inspection or to mislead or deceive the FDA investigator in a manner that prevents the investigator from conducting the inspection;

• Refuses to allow the FDA investigator to collect evidence to document potential violations (e.g., to take photographs as necessary; to collect samples; talk to pertinent staff; or to collect food labels and labeling);

• Leaves the FDA investigator in a non-production area of the establishment (e.g., conference room) without access to records, to a responsible individual, or to other areas of the establishment that would be subject to inspection for an unreasonable period of time.

The final guidance is scheduled to be published in the Federal Register on October 21 and can be reviewed here.