Recently, an importer of spices received a 483 from the FDA for failure to comply with implementation of FSMA’s Foreign Supplier Verification Program (FSVP) requirements. FSVP specifies that importers covered by the rule verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the FSMA preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling. Compliance with the various FSVP requirements must be documented.
As part of this, FSVP requires that importers identify and evaluate known or reasonably foreseeable hazards for each type of imported food to determine if there are any that require a preventive control. In this particular case, there was no documentation demonstrating that the foreign supplier’s hazard analysis had been reviewed and assessed. Further, the importer’s approval of the foreign supplier and evaluation of their performance and the risks they may pose were not documented; this is required under FSVP.
FSVP also requires that appropriate verification of the supplier’s activities be conducted and documented. The type of verification can be tailored to the specific supplier and could include onsite audits, sampling and testing or reviewing records. The records reviewed by FDA of these activities performed by this importer were incomplete or not fully documented.
It is very worthwhile to learn from this recent issue since it is commonly reported. Among the recently published summary of top FDA citations, development of an FSVP was reported more than 11% of the time. For a few years, this citation type has been the top ranked. Other FSVP-related violations have also been reported.
