FDA continued to aggressively enforce the Foreign Supplier Verification Program (FSVP) in 2023 with a steady set of Warning Letters, import alert listings, and import refusals.

When looking behind the numbers, there continues the same general pattern from the last few years: the importer failed two or three inspections and received a Form 483 each time, then they received a Warning Letter after either failing to respond to the 483 or responding insufficiently. The import alert listing then happened some time after FDA issued the Warning Letter.

The number of import refusals is down compared to last year (194 as compared to 644 lines), but 2022 may have been higher with one or more importers thinking that an import alert listing will not impact their ability to successfully import product. It does.

Click here for a refresher on the FSVP basics.