The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP) regulation. 1The thirteen-page document contains detailed checklists of the required records,, though not every record on the list will be applicable to every importer. These records need to be made available to FDA during an FSVP inspection. 2
As background, the FSVP regulation requires importers to verify that the food they are importing into the United States has been produced in a manner that meets applicable U.S. food safety standards. To do this, importers are required to develop, implement, and maintain an FSVP that includes documentation of verification activities for each imported food from each foreign supplier. 3 The FSVP regulation itself does not include a list of the specific records that are required to be maintained. (In contrast, the supply-chain program component of the Preventive Controls for Human Food (PCHF) regulation does include a list of required records.)
The new list issued by FDA is highly-detailed and should be a useful tool for importers. Likewise, this list could become a roadmap, of sorts, for FDA investigators during inspections. FDA is actively enforcing the FSVP regulation and routinely requests that importers provide copies of all FSVP records related to the import entry that is the focus of the inspection. Accordingly, importers may want to consider using this list to guide an internal inspection-readiness audit, or to assist with the development of their FSVP if they do not already have one.
1/ FDA Publishes List of Records Required Under FSVP (October 7, 2019) (FDA Constituent Update), https://www.fda.gov/food/cfsan-constituent-updates/fda-publishes-list-records-required-under-fsvp.
3/ 21 CFR § 1.500 et seq.
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