When Refusing a Picture During a Food Inspection Could Prove CostlyOctober 27, 2022
The question of whether FDA has authority to take pictures during an inspection of a facility has bounced around the food and drug bar for many years. FDA’s view is stated in the agency’s Investigation Operations Manual, and it is one with which a number of practitioners disagree. To date, neither side has sought to take the issue to the mat in a way that would definitively resolve the dispute. In the interim, the issue has reared its head again in FDA’s recently issued guidance for industry, titled Refusal of Inspection by a Foreign Food Establishment or Foreign Government.
As the name suggests, the guidance explains the circumstances under which FDA will conclude that a foreign food establishment or foreign government has refused inspection, and the consequences that could flow from that refusal. In part, the guidance states:
In the domestic context, FDA has authority to compel inspection, namely, when a domestic firm refuses inspection completely or refuses to permit us to fully conduct an inspection (e.g., refuses to provide access to applicable records, refuses to permit the investigator to take photographs as necessary or refuses to permit sample collection), FDA may seek an inspection warrant to compel the inspection.
* * *
We consider an owner, operator, or agent in charge of a foreign food establishment to have refused an inspection when an owner, operator, or agent in charge prevents the FDA investigator from fully conducting an inspection of the establishment, by establishing unreasonable preconditions to allowing the inspection or by preventing or interfering with completion of some aspect of the inspection. Examples of where we would generally consider preventing the FDA investigator from fully conducting an inspection include… [t]he owner, operator, or agent in charge 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).
Absent extraordinary circumstances, it seems unlikely that FDA would seek a warrant to compel a domestic firm to allow the taking of photographs. However, in the context of imports, FDA can more easily wield a much bigger cudgel.
As explained in the guidance, “[u]nder section 807(b) of the FD&C Act, FDA shall refuse admission into the United States of a food from a foreign food establishment of which the owner, operator, or agent in charge or the foreign government refuses to permit an inspection.” That refusal is executed administratively, with no need to involve lawyers or judges, and the results can be highly disruptive. The refusal likely would land the foreign food establishment on the Red List of Import Alert 99-32, Detention Without Physical Examination of Products From Foreign Establishments Refusing FDA Inspection. Once on the Red List, an establishment can try to get off by contesting FDA’s decision – likely an uphill battle – or can ask FDA to schedule an inspection. However, as pointed out in the guidance, it could take at least a year before FDA returns to the establishment for the inspection. That’s a long time to potentially lose access to the U.S. market.
The unfortunate scenario painted above is more than theoretical. As we’ve discussed in prior blog postings, FDA has already trod this path with respect to foreign drug establishments that allegedly prevented the taking of photographs. See here and here. Even though CDRH has not yet issued its own guidance about inspection refusals like the drugs, biologics, and food centers, it is likely that CDRH would take the same position about taking photographs during device inspections.
As an aside, a number of establishments from a handful of countries are already on the Red List in Import Alert 99-32. The vast majority of those establishments appear to be located in China, notwithstanding the fact that country purportedly accounts for a relatively small proportion of food imported to the U.S.