The U.S. Food and Drug Administration (FDA) regulates compliance with the Foreign Supplier Verification Program (FSVP) rule for US facilities that import food products from outside of the United States. Importers must have FSVPs for each product they import from each supplier verifying the products follow applicable FDA regulations. The FDA ensures established FSVP's upon their inspections, even during remote inspections, which have been conducted regularly during the COVID-19 pandemic. Additionally, companies like UPS and FedEx ask for FSVP verification in order to clear packages upon arrival into the USA.
What's the FDA looking for in these inspections?
FDA has increased focus on FSVP, and is actively issuing Warning Letters for violations. With a rate of six times more, the Warning Letters issued in 2020 were related to FSVP violations. #FDA may also choose to add offending importers to Import Alert 99-41, which targets the importers in non-compliant standing with FSVP.
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. Additionally, 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. Read more about these violations from our previous blog here.
Violations can create costly delays for affected importers.
What are some mistakes I can avoid?
Under the Food Safety Modernization Act (FSMA), most food importers are required to develop and maintain FSVPs for their foreign suppliers. This requires importers to perform certain activities to ensure their suppliers are FDA compliant and producing goods in a safe and acceptable manner. If you are importing teas, herbs, primary packaging, or having your product produced outside the US you are required to have FSVPs in place.
Violations can create costly delays for affected importers. Warning Letters have been issued by the FDA when a facility did not have FSVPs for their imported ingredients used to make a final sellable product. 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 delays in an already slowed transport era.
Warning Letters can be issued when a company does not properly approve a 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.
FDA may also issue Warning Letters for not properly verifying supplier compliance. A company was cited for not conducting proper hazard analysis on one of their suppliers because the company did not meet requirements. The facility also provided HACCP plans for imported products as an FSVP, however, HACCP plans do not satisfy the requirements of an FSVP and FDA concluded the company's #HACCP plans were deficient and did not provide the necessary information for FDA compliance.
The best plan to avoid a citation is preparation!
How do I avoid a citation?
The best plan to avoid a citation is preparation! When FDA inspects a food facility, the agent checks for compliance with current good manufacturing practices and any other applicable food safety regulations. Failure to comply can result in warning letters, citations, or detentions.
If you feel unprepared for an upcoming FDA inspection, you'll need an expert on your team - and we can help! Hula Consulting can help with your questions and documents, as well as assist in a mock-inspection (gap audit) visit to your facility and give you a detailed report on what is necessary to correct in order to pass an FDA inspection. Contact us today at 561.600.7025 or scott@hulaconsulting.com. We look forward to helping you with your business!