Just when you think you have opened your last gift, the federal government throws one last present under the tree…
Last week, FDA issued draft Guidance for Industry regarding the refusal of inspection by a foreign food establishment or by the food establishment’s foreign government. Feliz Navidad - Mutlu Noeller - Maligayang Pasko! Why should you care? Because FDA’s interpretation of “refusal” is as big as a barn and twice as wide and could very likely impact how happy your New Year will be.
To begin, keep playing this loop in the back of your mind: The Office of the Inspector General (OIG) just faulted FDA with failing to perform an adequate number of inspections pursuant to FSMA requirements. Brace for impact!
One of FDA’s new FSMA authorities is the right to disallow the import of food into the U.S. if the foreign establishment that produced the food refuses an FDA inspection. A “refusal of inspection” doesn’t just mean not answering FDA’s knock at the door. It means anything from not responding to FDA’s request within 24 hours to the facility’s foreign government not allowing the FDA investigator into the country on the scheduled day of inspection due to passport issues. Here is a partial list of what FDA considers a refusal:
Failure to Respond to an inspection request within 24 hours;
Lapse in Communication (unspecified time) once a conversation regarding inspection has begun;
False Information, e.g., “We’re not processing at this time…”;
Reschedule Request for something other than an issue beyond the party’s control, e.g., snow storm, mud slide, protest; and
Limitations on Access to a facility from imposing unreasonable restrictions on time, hygiene, etc.
Think about how scattered and disorganized some of your favorite foreign suppliers are and how loath they are to respond to your requests. Are you getting nervous?
Can the foreign facility ask for a reset? Of course, they can…this is the FDA we’re talking about, not the Grinch! However, FDA has warned that due to staffing, budget and workload issues, it could be at least a year before an inspection is rescheduled. During that time, the facility will NOT be allowed to ship its product(s) to the U.S. The FDA has a “Red List”—a list of foreign suppliers that have “refused” inspection. If a foreign supplier you are dealing with is on the Red List, product admission into the U.S. will be refused. End of story. A foreign supplier’s product(s) will remain on the Red List until an inspection has been conducted (about a year, unless FDA decides to teach the supplier a lesson…).
The reason that “refusal of inspection” is important to foodguys is because it could adversely impact your import business and your ability to keep your promises of price, time, and quality to your customers. Because of the OIG’s report, the FDA certainly will be initiating more inspections. Therefore, the foreign suppliers you contract with need to understand the importance of cooperating fully when faced with an FDA inspection request, because it is more likely than ever before that they will be on the FDA’s inspection roster.
I am going to prepare a memo to foreign suppliers informing them of the issues surrounding FDA inspection requests, so they can, at least, be aware of the impacts of refusing an inspection. I will make the memo available to all foodguys, and allow you the option of sending the memo to your foreign suppliers. Understandably, many foreign suppliers really don’t appreciate the impact of FSMA and the new authorities it grants to the FDA . So, don’t be afraid to bring up the issue. It’s in your best interest. Do what you can to help your foreign suppliers avoid finding themselves on a 12-month import alert. A casual conversation could be crucial to protecting your supply chain integrity.
Wishing You and Yours a Prosperous New Year!
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