The FSVP regulation requires importers to perform certain risk-based activities to verify that human or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.
Recently I have noticed several FDA Warning Letters for FSVP inspections. FDA appears now to be conducting FSVP-specific inspections, for example, in one letter they state:
“On June 28, 2019, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at your facility….This inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the Foreign Supplier Verification Program (FSVP) implementing regulation in 21 CFR part 1 subpart L.”
and, notably:
“At the conclusion of the inspection our investigator provided you with a Form FDA 483a, FSVP Observations.”
There seems to be a specific Form 483a which is used for these inspections. However, a search at FDA.gov did not yield a example of this form. For calendar year 2019, I found 315 citations in FDA’s citations database for failure to develop Foreign Supplier Verification Programs.
If you import ingredients, dietary supplements or foods, 2020 might be a good time to get your foreign supplier verification program on track, or take FSVP training!