Foreign Supplier Verification Program (FSVP)
FDA is now enforcing the FSVP rule which requires food importers to maintain documentation and records verifying that the foods they import meet US food-safety standards.
For the purpose of the FSVP, FDA defines the importer as the US owner or consignee of the imported food. FDA refers to this entity as the “FSVP importer.” If no US owner or consignee exists for the shipment, then the FSVP importer may be an agent or other authorized representative of the foreign supplier or owner. Each food from each of the importer’s suppliers must have its own, separate FSVP! For example, if you import bean paste from two different suppliers, then each bean paste must have its own FSVP. If you import bean paste and dried noodles from the same supplier then, again, each food must have its own FSVP. Certain foods such as foods that comply with the seafood or juice HACCP regulation are exempt from the FSVP requirement.
The FSVP activities must be performed, reviewed, and documented by one or more “qualified individuals.” FDA considers a qualified individual to be a person with the education and or experience that qualifies that person to perform an FSVP activity.
The FSVP activities include:
Hazard Analysis and Risk Evaluation – For each imported food, a qualified individual must identify and document all known or reasonably foreseeable food safety-related hazards including physical, chemical, and biological hazards. The qualified individual must then evaluate the risk of each hazard in terms of the severity of the hazard and the probability of the hazard occurring if it is not controlled.
Supplier Evaluation – A qualified individual must evaluate the food safety performance of the supplier. The Qualified Individual may consider factors such as any FDA inspections, third-party audits, effectiveness of any recalls, and any FDA regulatory actions taken against the supplier (e.g. warning letters, import alert listings, detentions, refusals, etc.). Note that FDA does not approve the suppliers. The importer must evaluate and approve their food suppliers and document that evaluation.
Verification Activity – The importer must routinely have a qualified individual(s) perform an activity that verifies that their supplier (or other entity responsible for controlling the food safety hazards) is effectively controlling the hazards. These activities may include on-site audits, private lab testing, or review of the supplier’s food safety records.
For example, if the importer’s qualified individual determines that Salmonella contamination is a reasonably foreseeable hazard for a food, then the company may choose to have a private lab periodically test the product for Salmonella. A qualified individual must determine the type and frequency of the activity. If the hazard could result in serious adverse health consequences or death, a qualified individual should conduct an onsite audit of the facility at least once a year.
Corrective Actions – A qualified individual must review and document any corrective actions taken by the supplier in response to any problems related to the safety of the food.
Re-evaluation of FSVP – The importer must have a qualified individual re-evaluate the FSVP at least every 3 years to ensure it is sufficiently meeting the requirements of the FSVP regulation. If the importer becomes aware of any changes or other new information that could affect the safety of the food, then the FSVP must be evaluated at that time as well.
Remember that a person FDA recognizes as a qualified individual must perform and document the above activities! Contact us FDA Specialist to assist you as the qualified individual for your FSVPs!
What Happens if You Fail an FSVP Inspection: FDA 483s, Warning Letters, and Import Alert
FDA is now placing importers on the Red List of Import Alert 99-41 “Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP) Regulation.” This is one of the rare Import Alerts on which FDA places US importers rather than foreign manufacturers and shippers!
All non-exempt food importers can expect to be inspected by FDA to ensure they have adequate FSVPs. FDA investigators will usually conduct FSVP inspections at the importer’s place of business. The inspections are random and may occur any time after the importer imports the foods. Most of the time, FDA will only give a week or less notice for the inspection!
During the first few years following the publication of the FSVP rule in 2017, FDA was lenient in its FSVP inspections and would simply provide non-compliant importers educational materials, advising them how to comply with the FSVP regulation and prepare for future FSVP inspections. However, this “discretionary education” period has long ended. Now, if the investigator finds that the importer does not have FSVPs for all their non-exempt foods or that the FSVPs are inadequate, he or she will likely issue FDA Form 483 to the importer, listing all the investigator’s observed violations of the FSVP regulation
If the importer fails to correct the violations, FDA may issue a Warning Letter advising the importer that the Agency may take enforcement action if the problems remain unresolved. Warning Letters are published on FDA’s public website, so you should avoid the Warning Letter at all costs!
If the importer is still unable to correct the violations after being issued the Warning Letter, FDA may place the company on the Red List of Import Alert 99-41 under which FDA may now automatically detain the importer’s foods as long as the importer remains on the list. To be removed from the Red List, the importer will need to petition FDAs’ Division of Import Operations, a process that may take several months or longer.
Be sure to contact us to see how we can assist you in ensuring that you pass FDA’s FSVP inspection!