This is an official notification that the United States Food and Drug Administration (U.S.FDA) is planning to conduct an inspection at your food facility in the near future.
Getting such a notice is bound to get any food manager’s heart beating faster, but having the FDA show up at your door without such advance notice is even more unnerving. But with the FDA’s recent notification that it is expanding its use of unannounced inspections at foreign manufacturing facilities, that is a lot more likely to happen than it was in the past.
There is, however, some relief for Canadian facilities, in that most are covered by the Food Safety Systems Recognition Agreement (FSSRA), so should have a lower frequency of FDA inspection. Because the FSSRA affirms a recognition that the US and Canada have comparable control measures and systems as they relate to the safety of food, the CFIA stated that FDA is primarily targeting companies in Canada that export products to the US not covered by the FSSRA (e.g. dietary supplements).
This is not to say, however, that the FDA won’t show up at your door – announced or unannounced, as the agency is well behind in the number of foreign inspections it is required by the US Food Safety Modernization Act (FSMA) to conduct each year. Of the 125,000 foreign food facilities subject to FDA inspection under FSMA, FDA had conducted fewer than 1,000 foreign inspections annually – far fewer than the 19,200 required by FSMA. So, the overarching goal is for the agency to increase its foreign inspections significantly to ensure that these manufacturers are adhering to the same food safety standards required of domestic manufacturers. Additionally, because a FSMA regulation covers animal foods, Canadian pet food manufacturers are subject to the FDA unannounced inspections, as well.
Manufacturers can also expect future inspections to be more rigorous, because, even when advanced notice was provided at foreign facilities, inspectors found serious deficiencies more than twice as often as at domestic facilities. Thus, FDA is also evaluating its foreign program policies and practices to heighten oversight and help to “expose bad actors” (e.g., those who falsify records, conceal violations, etc.). Additionally, the FDA notice was published to clarify policies that inspectors cannot accept any travel accommodations from regulated industry, including lodging and transportation arrangements, the goal of which is to maintain the integrity and objectivity of the oversight process.
When intending to conduct an announced inspection, the FDA sends a Notice of Inspection with the request for the firm to complete a Factory Profile form. With a notification also sent to CFIA as a courtesy, CFIA will sometimes ask to send an inspector itself to observe the FDA inspection. FDA will want to inspect the facility while it is in operation, though it does not have to be producing food for the U.S. market at the time of the inspection. The facility is requested to respond to the inquiry within five days, following which FDA will contact the firm to confirm specific dates.
For foreign facilities unfamiliar with FDA inspections, there are a few important things to note:
- If a facility denies access to FDA for an inspection, whether it be announced or unannounced, FDA can take regulatory action including import refusals.
- Following an inspection, the firm may be issued a Form 483 if the FDA determines a lack of compliance with the inspector’s observations classified in three ways: No action indicated (NAI) – no objectionable conditions or practices were found during the inspection; Voluntary action indicated (VAI) – objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action; and Official action indicated (OAI) – regulatory and/or administrative actions are recommended.
- When objectionable conditions or practices are found, the firm is given 15 business days to respond to the 483 in which they have to explain how they will take corrective action and respond to FDA. If action is not taken, or if FDA has continuing concerns with the facility’s response, it can issue a warning letter, which can lead to the facility being placed on an import alert red list.
While Canadian facilities under FSSRA are somewhat less likely to be impacted by the FDA’s expansion of unannounced foreign inspections, the potential for an inspector unexpectedly showing up at your door is still more likely than it was in the past. And the repercussions for not being prepared can be grave. With TAG Canada’s cross-border operations and industry expertise, we can be of value in assessing your facility to help ensure you are prepared, and you stay on the right side of regulation. Give us a call for information or assistance!
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