Still Using UNK? Time to Update Your FSVP!
In 2021, more than half of the importers whose Foreign Supplier Verification Programs (FSVPs) were assessed by FDA received 483s for a non-compliance. FDA also issued 58 Warning Letters in 2021 – a number which appears to be likely surpassed in 2022, with 29 FSVP-related Warning Letters already issued by the end of May.
Now there is another factor that is likely to increase the number of importers dinged for FSVP non-compliance issues. That is: In less than a month, the previously allowed use “UNK” in the Entity Number field will cause a rejection by the Customs and Border Protection (CBP).
On April 27, FDA issued an updated guidance document discontinuing the temporary approval for importers to use unknown (UNK) as the unique facility identifier (UFI) code, effective July 24. 2022. The only UFI that will be recognized as acceptable by FDA for importer identification is a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number that corresponds with the entity’s U.S. location.
Last week, FDA reiterated this new requirement with a 30-day notice of the “UNK” nonacceptance, stating that as of July 24, “CBP will reject an entry line of a food subject to the FSVP regulation when the FSVP importer’s DUNS number is not provided in the Entity Number field.”
The change makes for one more reason that a shipment could be rejected at the border. With the top five reasons for FSVP non-compliance in 2021 being:
- No FSVP (794)
- No Hazard Analysis/Incomplete (78)
- Evaluation based on risk of food not conducted (74)
- No supplier approval documentation (71)
- No written procedure for only using approved suppliers (69)
Could “lack of acceptable DUNS number” become the sixth, or even replace one of these as a top-five cause?
Ensuring FSVP Compliance
To assist businesses with compliance, TAG has presented webinars, TAG Talks, and Insights articles on Avoiding FSVP 483s. In this article, we provide (and update) additional information and a list of areas to assess to help you stay in compliance.
Important to understand is that the FSVP consists of all records and documentation that demonstrate compliance with applicable FSVP requirements for a particular imported food product and/or foreign supplier. While the FSVP doesn’t have a set format, allowing for flexibility the rule is made up of a set of requirements that must be met which are specific to the circumstances of a particular food and/or supplier. It also requires that everything be documented, and cumulative records be retained demonstrating how you’ve implemented the FSVP requirements.
A few key elements to consider in assessing your FSVP for compliance include:
- Ensure that your records have your accurate U.S. location DUNS number in the Entity Number field. If you do not have a (or need to look up your) DUNS number, you can do so at Dun & Bradstreet at no cost.
- Ensure you have a properly trained FSVP qualified individual (QI) with documentation of their training.
- Check your imported foods to be sure you have an FSVP for each article of food you import from each supplier’s location (when there is more than one facility location from which you will be importing).
- If the supplier verification documentation is about to expire (such as a GFSI audit), ensure you re-evaluate, and date the FSVP appropriately.
- Review and stay up to date on all supplier events. For example, has the supplier been in any recall? Are they on any Import Alerts? Did they receive a 483, or a warning letter? Did they have a poor audit? If the answer is “yes” to any of these, did they appropriately perform a corrective action? If not, what is your proper corrective action?
- Review your Foreign Supplier Approval Program to ensure it:
- Details how you approve suppliers and what documents are acceptable (e.g., SOP).
- Has been signed and dated by the QI.
- Has a complete Hazard Analysis (See Appendix 1: Potential Hazards for Foods and Processes)
- Review your records: Are they in English? Did you retain them for two years after you discontinued using the Foreign Supplier/food article or the FSVP expired?
In partnership with SafetyChain, TAG also provides an FSVP infographic with the framework of the above as a quick reference for compliance.
With the U.S. importing about 15% of its food supply from more than 200 countries and territories, it’s not surprising that some shipments may be rejected for not meeting the same preventive food safety standards that apply to food produced in the U.S. – as is the purpose of the FSVP Rule. But taking some extra time to review your FSVP to ensure it meets all requirements, including the new no-UNK rule, will help to ensure you receive your foreign ingredients and products where and when you need them – without CBP or FDA rejection.