Whether you are a foreign supplier of food to the U.S. or you import food or ingredients, there are a number of dos and don’ts to know – and pass along to your suppliers – about FDA foreign facility inspection authorities and the consequences of refusals.
The authority to inspect foreign food establishments that offer food for importation into the U.S. has been an authority that FDA has had in the past but the requirement to do more foreign inspections was imposed on FDA through FSMA. The Act also gave FDA authority to refuse entry of the food if the inspection is refused by the food establishment or the foreign government. In October, FDA issued guidance on what constitutes a refusal along with information on how the agency schedules and conducts foreign inspections. Following are some key points on the scheduling and conducting of the inspections and definitions and consequences of refusal.
Scheduling. FDA is not required to announce foreign facility inspections. However, its general practice is to contact the firm to facilitate the process and ensure that records and personnel will be available. FDA coordinates with both the establishment and the government where the establishment is located, first sending a written request to the government on its intent to inspect food establishment(s) in the country, then notifying each facility. Once scheduled, FDA provides the foreign government with written confirmation of the dates.
The inspection. The FDA investigator typically observes the areas of the food establishment where regulated foods are grown, harvested, manufactured, processed, prepared, packed, or held and areas that may impact these operations. The investigator may review related records, as authorized by law/regulation, take photos, and collect samples (e.g., environmental, finished product, raw material, and in-line/in-process material). Reasonable delays to records requests are generally accepted if a good faith effort is made to comply. Foreign government representatives also may accompany the FDA investigator on the inspection.
Inspection Refusal. If a foreign entity is not paying attention, it is easy to end up with a refusal and all the consequences. If the owner, operator, or agent in charge of a foreign facility does not respond to a written FDA inspection request (which may be sent by email, fax, mail, or express courier) within 24 hours of receipt, it will be considered a refusal. In addition, any “statements, actions, and passive behaviors” that prevent or delay FDA from scheduling or fully conducting an inspection, are intended to avoid inspection, or are intended to mislead or deceive the FDA investigator from conducting the inspection will be considered a refusal. While a request to delay/reschedule the inspection based on an unforeseen event or situation (e.g., severe weather that prevents operations) will not be considered a refusal, FDA may request documentation of the situation.
Additional examples of what FDA considers to be refusals include:
- A refusal can be as simple as not cooperating in the scheduling of an inspection. In addition to not responding within 24 hours, an incomplete or inaccurate response, not accepting an inspection date, or agreeing to a date then requesting a change without reasonable explanation are all considered refusals.
- Refusing to allow FDA to conduct the inspection is any situation in which an owner, operator, or agent in charge prevents FDA from entering the establishment; does not answer calls from the investigator who arrives at the facility but is unable to enter; or stops production during the inspection without reasonable explanation.
- Preventing a full inspection is also considered a refusal. Examples are: if the investigator is barred from operational areas, is allowed only an unreasonably short period of time, is made to leave before the inspection is completed, or is not allowed to collect evidence; if manufacturing is discontinued during the inspection without a reasonable explanation; or if record access is unduly limited.
- Causing unreasonable delays in the inspection can also be considered a refusal. For example, if access to a needed area is delayed until a future date or time even though operations are in process, or the investigator is left in a nonproduction area for an unreasonable amount of time without access to records, a responsible individual, or other areas that would be subject to inspection.
Additionally, while the foreign facility may have no control over its government, that government’s refusal to allow FDA entry into the country or inspection of a facility would cause the facility’s food to be placed on Import Alert and could eventually cause all the country’s foods to be refused entry into the U.S.
The Consequences. As authorized by the FD&C Act [807(b)], a foreign facility (or its government) which refuses an FDA inspection will be placed on the Red List of Import Alert 99-32, and its food product(s) refused entry into the U.S. The facility would need to submit a request to schedule an FDA inspection to enable removal from the Import Alert.
It is easy to see that there are a number of ways that a foreign food/food facility can end up in a refusal situation and as a result be placed on Import Alert and thus refused entry into the U.S., some of which may easily and unintentionally occur – such as a facility owner not regularly checking their email and missing a 24-hour response deadline. With attempts to delay an inspection, halt production during the inspection, or restrict the investigator’s time or access all considered as a refusal, it is important that foreign facilities understand inspection requirements and repercussions.
TAG would also advise that U.S. food facilities maintain good communication with the foreign facilities with which they work, their foreign suppliers and their importers of record, ensuring they understand FDA’s authority and are prepared at any given time for an inspection. The lack of a response or the use of a delaying tactic on the part of a foreign supplier can mean the absence of needed food or ingredients for your final product.