FSVP Inspections on the Rise

Ron Tanner | 27 Oct 2021

FDA has moved into more aggressive implementation of the Foreign Supplier Verification Program rule that is part of the Food Safety Modernization Act, with more than 2,100 inspections having taken place since 2019. Plus, warning letters are on the increase.

In FY 2022 (October 1, 2021 – September 30, 2022), 1,900 FSVP inspections are planned, almost as many as have taken place in the past four years. More than 1,300 of those will be re-inspections of importers who needed to take action after their initial inspection.

“The importer community has been slow to respond to the FSVP regulations,” said Selina Mata, Supervisory Consumer Safety Officer, FDA, speaking at the Food Safety Preventive Controls Alliance conference that took place last week. “We continue to educate them about their responsibility but expect companies to comply after an initial inspection.”

In April 2020, FDA announced that it would be doing remote FSVP inspections. Some situations, such as an expected foodborne illness, have triggered on-site inspections. Moving forward, FDA plans to do a mix of remote and on-site inspections. The advantages of remote inspections include: convenience (elimination of travel); efficiency (ability to conduct multiple inspections simultaneously; and decrease in stress and intimidation.

The numbers show that importers are not implementing FSVP programs as quickly or as thoroughly as necessary. Almost 64 percent of those inspected since 2019 have failed, under the designation of VAI, or Voluntary Action Indicated. These are the primary reasons:

• Did not develop an FSVP

• Did not develop a Hazard Analysis

• Did not document that a foreign supplier’s food safety plan was conducted

• Did not document that a foreign supplier’s food safety plan was approved

• Did not establish written procedures that you import food only from approved suppliers

Mata observed, “FSVP importers need to document how they approve foreign suppliers and need to be able to explain their approach to inspectors.”

Warning Letters Increase

Whereas most importers are just asked to do Voluntary Actions, FDA has significantly increased its issuance of Warning Letters. In FY 2019, 1 was issued; 45 were issued in FY 2020, and 58 were issued in FY 2021.

Continued non-compliance after a Warning Letter can result in the issuing of an Import Alert 99-41. This alert specifically targets U.S. importers, who can be added to the Red List. FDA may detain, without any physical examination, any foods imported by an importer identified on the Red List, for the foods identified in the list.

Related: Implementing FSMA In an Almost-Post-COVID-19 World; FDA Releases Food Safety Blueprint.