When is a foreign inspection “refused”? FDA final guidance provides clarity

The US Food and Drug Administration (FDA) issued its final Refusal of Foreign Inspection Guidance on October 20 describing the actions, behaviors, and statements of a foreign food facility or a foreign government that would constitute a refusal of an FDA inspection. 

A foreign food facility that refuses an FDA inspection may find itself placed on the “Red List” – meaning its products could potentially be refused entry into the United States.  This authority to refuse entry is set out in the FDA Food Safety Modernization Act (FSMA) to help level the playing field between domestic and foreign food facility inspections.  It provides FDA with an enforcement tool to help ensure FDA has access to foreign food facilities, since, domestically, the agency can seek a US court order to compel an inspection. 

While domestic inspections are typically unannounced, FDA generally pre-announces foreign inspections.  This conserves scarce foreign inspection resources by ensuring that appropriate records and personnel will be made available when the FDA investigators arrive at the foreign facility. As part of the process, FDA coordinates with both the foreign food establishment to be inspected and the foreign government or competent authority of the foreign country in which the establishment is located. 

Criteria for refusal

The Refusal of Foreign Inspection Guidance states that FDA may consider an inspection to be “refused” when:

• the owner, operator, or agent in charge of the facility prevents or delays the FDA from scheduling the inspection (eg, failure to communicate with FDA after initial agency request; changes to the agreed upon time/date without reasonable explanation)
• the owner, operator, or agent in charge of the facility prevents the FDA investigator from conducting an inspection (eg, failure to permit entry when the FDA investigator arrives; refusal to allow the FDA investigator access to key locations within the facility without reasonable explanation; failure to operate the establishment when the FDA investigator arrives at the scheduled time without reasonable explanation; leaving the FDA investigator in a non-production area of the establishment, such as a conference room, without access to records, to a responsible individual, or to other needed areas of the for an unreasonable period of time that interferes with the investigator’s ability to complete the inspection)
• the foreign government prevents or delays the FDA from scheduling the inspection (eg, refuses to allow an FDA investigator to enter the country, for instance by denying a visa, without a reasonable explanation) or
• the foreign government prevents the FDA investigator from entering the establishment (eg, fails to permit entry when the FDA investigator arrives; refuses to allow the FDA investigator to take photographs as necessary; prevents or limits the collection of samples for analysis).

Consequences

A consequence for refusing an FDA inspection may be that the establishment is placed on the “Red List” of Import Alert 99-32. 

Notably, the owner, operator, or agent in charge of the establishment as well as the foreign government all have opportunities to contest FDA’s decision, as well as to request removal from the Red List.

Learn more about the implications of the Refusal of Foreign Inspection Guidance by contacting the author or your usual DLA Piper attorney.