The guidance is titled “Refusal of Inspection by a Foreign Food Establishment or Foreign Government.” It lays out the agency’s policies on scheduling inspections of foreign facilities and what constitutes a ‘refusal.’
Don’t obfuscate; don’t delay
Inspections of domestic dietary supplement and food manufacturing facilities are generally carried out without prior notice. For obvious reasons, FDA wants to be able to observe the true day-to-day operation of a facility, not the Potemkin village version. While this is the ideal, it is impractical for foreign food facility inspections, some of which must be arranged through the governments themselves. The agency works around seasonal factors for these facilities, and uses multiple modes of communication in scheduling these visits.
There can be a number of twists and turns in this relationship, and FDA has sought to put down in writing what it considers to be a ‘refusal.’ If the agency gets the impression that a facility operator is merely playing for time when it says it is having difficulty complying with the request, that action can have serious consequences.
Among the factors laid out in the guidance that might constitute delaying tactics that constitute a refusal are if the owner, operator or agent charge:
“Stops communicating with us at any time after the owner, operator, or agent in charge initially responds to our request to schedule an inspection,
Provides an incomplete or inaccurate response (e.g., an owner, operator, or agent in charge falsely claims the establishment is not operating or does not ship food to the United States),
Rejects FDA’s attempt to schedule an inspection by not agreeing to an inspection start date and does not give a reasonable explanation for its failure to do so, or
Agrees to an inspection start date and then requests a later date without giving a reasonable explanation.”
If the inspector actually gets to the facility, the refusal factors are if the inspector is refused entry on the scheduled day, if unreasonable conditions are put on the inspection, or it the inspector is delayed in entering the facility or is held up while the inspection is taking place.
Much of this has already been standard operating practice, said Russell Statman, executive director of Registrar Corp., a firm that acts as the US agent for hundreds of foreign food facilities.
“What they deem a refusal is not new. For domestic facilities FDA has always given no notice. For foreign governments, they have been sensitive to the notion that an agency of another government wants to just show up to inspect a facility in their country,” Statman told NutraIngredients-USA.
But what is new, Statman said, is the new deadline attached to these requests. In a prior notice FDA had mentioned a five day window. But now in this era of almost universal Internet coverage and so much business communications transacted via e-mail, that has changed.
“This is the first time they’ve ever put this down in writing this way. In this guidance it now says 24 hours. They might still get back to you and say, hey, you didn’t respond. They might not act on that, but they have the power to do so,” he said.
Statman said the key takeaway is that trying to put conditions on an inspection, trying to claim a registered facility is not in fact producing product when it pretty clearly is, or otherwise trying to limit an inspection’s reach will all fall into the realm of a refusal.
“Really anything beyond unconditional acceptance of an inspection constitutes a refusal,” Statman said.
Going on import alert is a damaging situation
Once FDA deems a refusal has taken place, the facility will be put on export alert, meaning none of its shipments will make it to their destinations in the US. To get this ban lifted, the facility must schedule and accept another inspection. But with FDA’s crowded schedule and limited resources, a reinspection might take as much as a year, Statman said.
It points to the importance for foreign facilities to have a professional US agent, Statman said. All too often, as a matter of cost or expediency exporters might simply choose someone they know who lives in the US, possibly even a family member, to act in this role. The issue with this choice is that this is not merely acting as a point of communication; US agents of foreign firms now have specified legal responsibilities under the Food Safety Modernization Act (FSMA), which could run into financial liability. The worst choice, Statman said, is to have a US-based customer act as the agent, as the interests of the two parties might diverge, and the foreign facility might find itself at a disadvantage.
“That’s really the worst choice; I tell clients you are really better off using your Uncle Joe as your agent, even with as poor a choice as that might be. The best choice is to use a firm like ours or one of our competitors or a law firm as your US agent,” he said.