FDA Actively Enforcing FSVP Regulations during Inspections; Issues Warning Letters to 31 Firms
The U.S. Food and Drug Administration (FDA) often inspects food importers for compliance with the Foreign Supplier Verification Program (FSVP) rule. During these inspections, FDA may ensure that importers have established an FSVP. So far this year, 7% (31 letters) of Warning Letters that FDA has issued were related to FSVP violations. This represents an increased focus on FSVP enforcement compared to 2019, in which only five facilities received Warning Letters for FSVP violations.
Even during the COVID-19 pandemic, FDA has continued remote FSVP inspections and is actively issuing Warning Letters for violations. FDA may also choose to add offending importers to Import Alert 99-41, which specifically targets importers that are not in compliance with FSVP. FDA has added importers to this alert as recently as July 2017.
FDA requires most US facilities that import food products from outside of the United States to develop FSVPs. Importers must have FSVPs for each product they import from each supplier that verify the products follow applicable FDA regulations, such as Preventive Control requirements. Under FSVP, importers must also consider their suppliers’ compliance history, including whether the products are under Import Alert and whether the facility has been issued a Warning Letter. Importers must reevaluate their suppliers at least once every three years.
If an importer fails to develop an FSVP, has an incomplete FSVP, or does not reevaluate their suppliers as required, FDA may take enforcement action.
Violations for Not Developing an FSVP
In June 2020, FDA issued a Warning Letter to Martinez Mexican Produce LLC after an inspection revealed the facility did not have FSVPs for their imported mayonnaise and shredded coconut products. FDA explained that it “may place all foods from your foreign suppliers on detention without physical examination (DWPE) when you import the products” if FSVPs are not developed. Products subject to DWPE will be stopped each time they arrive at the US border, resulting in continuous costly delays for affected importers.
Other examples of importers cited for not having FSVPs in 2020 include:
Violations for Incomplete FSVPs
FDA may also issue Warning Letters for not properly verifying supplier compliance. Kradjian Importing Company, Inc. was cited for not conducting proper hazard analysis on one of their suppliers. FDA stated that Kradjian “did not meet [their] requirements to conduct a hazard analysis…because [they] did not evaluate [their] foreign supplier’s performance in accordance with 21 CFR 1.505, nor did [they] perform foreign supplier verification.” The facility also provided HACCP plans for imported products as an FSVP. HACCP plans do not satisfy the requirements of an FSVP, and FDA concluded Kradjian’s HACCP plans were deficient and did not provide the necessary information for FDA compliance.
Kaymile Trading, Inc. was issued a Warning Letter because, in addition to missing FSVPs for several of their products, they did not properly “approve [their] foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food.” It is important for facilities to not only develop their FSVPs but to properly verify and evaluate foreign suppliers’ compliance with FDA food safety requirements. Under FSVP, it is the importer’s responsibility to verify that their suppliers are meeting FDA food safety standards.
Reduce Your Risk – Get Assistance with FSVP
Registrar Corp assists with FSVP compliance. Our online FSVP training will help your team understand what FSVP is, who is responsible for compliance, and how to meet requirements. If you don’t want to navigate these requirements on your own, Registrar Corp’s Qualified Individuals can develop, review and implement your FSVP for you. If you already have developed FSVPs, Registrar Corp offers a Mock FSVP Inspection service during which a Food Safety Specialist examines your FSVP documentation to identify any areas of concern.
Additionally, Registrar Corp’s FDA Compliance Monitor helps you comply with FSVP supplier evaluation requirements by continuously monitoring your suppliers for Warning Letters, Import Alerts and more. The Monitor allows you to track which suppliers you have approved and provides information from five FDA databases in one convenient dashboard. Receive email alerts when new information is published about your suppliers so you can make informed purchasing decisions and take necessary corrective actions.
For more information, contact us at +1-7579323884 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat