How to Manage CFIA or FDA Regulatory Visit?
- November 10, 2020
- Posted by: Felicia L
- Category: Food Safety
Handling Regulatory Visits
Regulatory visits can be stressful, especially when it comes to an unannounced audit. The Canadian Food Inspection Agency (CFIA) or US Food and Drug Administration (US FDA) is authorized to visit any of its registered and licensed sites without the need to announce the visits, as per the Safe Food for Canadian Act and US Food Safety Modernization Act. That means, if CFIA or US FDA like to visit a food facility, they can do so, and the facility management must provide access to the food facility within a reasonable time frame. This would also be applied to the foreign facility registered as US Foreign Supplier.
In most cases, the CFIA inspector will provide information ahead of their visit to ensure the facility is ready with the documentation. There are many reasons why CFIA visits a food facility. Contrary to the common belief that most people have with regulatory actions, CFIA visits can be due to initial inspection, regular inspections or regulatory visits (to investigate complaints or food safety incidents (An Exporter’s Guide to Canadian Food Inspection Agency (CFIA) Inspections, 2015).
We will discuss some tips to facilitate an announced CFIA visit in the next section. Let’s dive into the different types of inspections and understand the motivation of these inspections.
| Types Of Inspections | Motivation |
| Initial Inspection | 路聽聽聽聽聽聽聽聽 Initial inspection to approve facility licenses.
路聽聽聽聽聽聽聽聽 To review if basic food safety systems are in-place |
| Regular Inspection | 路聽聽聽聽聽聽聽聽 Routine (Annually, every few years) -frequencies depends on the risk of the products and compliance level of the company
路聽聽聽聽聽聽聽聽 Typically, the CFIA inspectors will indicate a few programs they would like to review as part of random sampling for compliance monitoring. |
| Follow Up Inspection | 路聽聽聽聽聽聽聽聽 Suppose there are any deviations found during the initial or regular inspection. In that case, the food manufacturer may be asked to correct the non-conformance.
路聽聽聽聽聽聽聽聽 For example, the cleaning and sanitation program is not documented. 路聽聽聽聽聽聽聽聽 CFIA inspector may perform the follow-up inspection or request evidence to support the non-conformances are properly corrected and documented. 路聽聽聽聽聽聽聽聽 Important note: Correcting the identified issues is important to prevent regulatory actions such as the Safe Food Canadian license suspension or cancellation. |
| Investigation Inspection | 路聽聽聽聽聽聽聽聽 Typically arise due to customer complaints, recalls or regulatory findings. For example, the product does not meet shelf life, product label claims, and product label missing allergen.
路聽聽聽聽聽聽聽聽 CFIA may visit request information to ensure the SFC regulations are followed |
| Inspection To Provide Export Certificate | 路聽聽聽聽聽聽聽聽 Requested by the food manufacturer to fulfil export requirements.
路聽聽聽聽聽聽聽聽 Example, Destination Inspection Service (DIS) for inspection of fresh fruits and produce. |
By understanding the inspection’s purpose, you could provide the right information and documentation to the CFIA inspector. At all times, the food facility representative must assist the CFIA inspector as much as possible by providing evidence and supportive documents, as requested. It is important to note that all information must be supported by documentation. An announced audit provides you with significant advantages. It allows you to gather these documents, so please take advantage of the nature of the audit. Be ready with the supportive documents as detailed as possible.
Here are a few additional strategies to facilitate CFIA’s investigation.
| Investigations | Action Plan |
| Food Safety Issues Or Food-Borne Illness | 路聽聽聽聽聽聽聽聽 Request clear information and get the details of the incidents.
路聽聽聽聽聽聽聽聽 Whenever possible, request the incident record and evidence. 路聽聽聽聽聽聽聽聽 Document the complaint on Complaint Management Form or Log 路聽聽聽聽聽聽聽聽 Cooperate with CFIA to investigate the reason for the flood incident. 路聽聽聽聽聽聽聽聽 Whenever regulatory samples are obtained, obtain two duplicate samples and keep as a retention sample. 路聽聽聽聽聽聽聽聽 Follow up with CFIA to resolve the issues
|
| Product Label Claims Complaint | 路聽聽聽聽聽聽聽聽 Investigate if the claims are substantiated (if the claims are supported with evidence)
路聽聽聽聽聽聽聽聽 Provide the CFIA inspector with documented supportive evidence 路聽聽聽聽聽聽聽聽 Follow up with the CFIA inspector to resolve this issue |
| Routine Inspection | 路聽聽聽聽聽聽聽聽 Treat this inspection as a routine third-party audit by knowing the goals are to ensure compliance with the SFC regulations.
路聽聽聽聽聽聽聽聽 Collect and provide supportive documents, i.e., Standard Operating Procedures, Records and Reports. 路聽聽聽聽聽聽聽聽 For example, for SFCR Section 52 (Sanitation and Non-Chemical Agents), all chemicals must be identified and protected from misuse. You must ensure that you have a method to identify the chemicals and protect them from misuse. This method shall be documented, and evidence of how you follow the program shall be available. |
| Follow Up Inspection | 路 Follow-up inspection must not be taken lightly as CFIA have the power to suspend or terminate the SFC license.
路聽聽聽聽聽聽聽聽 You must ensure that all identified deviations are properly closed and documented 路聽聽聽聽聽聽聽聽 For example, if you have previously found that the chemicals are not secured from misuse, you must list the procedures and control measures used to lock and secure the chemical from misuse. |
The best way to manage CFIA requests for a visit is to stay calm and understand the reason for their visits so that you can be better prepared. Never reject the CFIA’s request for a visit regardless of their intention as the SFCR state that all regulatory visits must be permitted (Inspection Modernization, 2018).
Knowing the intention and how to navigate through CFIA inspections are very important so that the food facility can focus on facilitating the inspection activity. Regardless of announced or unannounced regulatory visits, we have to remember that the CFIA’s goal is to ensure SFCR regulations are followed. Therefore, if you are a food manufacturer following the SFCR regulations, CFIA visits can be considered the third-party certification audit. Besides, having the right documents and well-implemented procedures certainly helps to be audit-ready at any time.
SFPM Consulting focuses on building regulatory trusts by assisting food manufacturers in preparing and meeting SFC regulations compliance.
References
An Exporter’s Guide to Canadian Food Inspection Agency (CFIA) Inspections. (2015, March 20). Retrieved from Government of Canada: https://www.inspection.gc.ca/about-cfia/transparency/regulatory-transparency-and-openness/rights-and-service/exporter-s-guide/eng/1326310774884/1326310889656
Destination inspection service (DIS). (2020, June 8). Retrieved from Government of Canada: https://www.inspection.gc.ca/importing-food-plants-or-animals/food-imports/food-specific-requirements/dis/eng/1303744846703/1303744928454
Inspection modernization. (2018, March 7). Retrieved from Government of Canada: https://www.inspection.gc.ca/about-cfia/strategic-priorities/inspection-modernization/eng/1337025084336/1376482277925
What to expect when you’re inspected. (2018, November 21). Retrieved from Government of Canada: https://www.inspection.gc.ca/about-cfia/strategic-priorities/inspection-modernization/what-to-expect/eng/1515000729834/1515001107571