FDA Has Started Inspecting U.S. Importers for FSVP Compliance
As of May 30, 2017, most U.S. importers of food and beverages for human and animal consumption are required to comply with the U.S. Food and Drug Administration’s (FDA) Foreign Supplier Verification Program (FSVP) rule. Since the compliance deadline, Registrar Corp is aware that importers have begun receiving emails from FDA with the subject line: “FSVP Inspection Requirements, Handouts & Law.” This email informs importers of an upcoming FDA inspection to examine their compliance with FSVP requirements. In light of these recent events, Registrar Corp provides importers with pertinent information to be prepared for a possible FSVP inspection.
What is a FSVP?
The FSVP rule requires U.S. importers of food and beverages to designate a “Qualified Individual,” defined by FDA as possessing either appropriate training or job experience reflecting the ability to develop a food safety system, to develop FSVPs for each food from each foreign supplier. This means that multiple foods from a single supplier or multiple units of a single food from multiple suppliers each require individual FSVPs. FSVPs require several components including hazard analysis, an evaluation of risk and supplier performance, documented supplier verification activities, and a plan for corrective actions should a supplier be found non-compliant.
In a single FSVP, a hazard analysis of the food item should be conducted, identifying any potential and foreseeable biological, chemical, or physical hazards that could cause illness or injury in the absence of preventive measures. The importer should assess the probability and severity of the illness or injury should these measures not be implemented, while considering a diverse array of variables, such as manufacturing procedures, raw materials and ingredients, and the transportation, storage, and distribution of the food.
An evaluation of risk and supplier performance should consider the results of the hazard analysis while assessing the supplier’s food safety practices and procedures, its compliance with U.S. food safety regulations, as well as its history of correcting food safety problems to determine the level of health risk when importing from the supplier. Importers should determine appropriate verification measures relative to the level of food safety risk the supplier poses. Verification activities may include onsite audits, sampling, and/or review of the supplier’s food safety records.
Provided any food safety issues arise, an importer is required by FDA to take the proper steps toward correcting the issue with the supplier. Corrective Actions may vary depending upon specific issues, and in severe cases, may require the importer ceasing business with the supplier until they are found compliant. One such issue may be that a supplier is lacking a Food Safety Plan as required under the FSMA Preventive Controls rule. Registrar Corp is experienced in the development of these plans and can assist the supplier in becoming compliant so both parties may continue business.
What Does a FSVP Inspection Look Like?
According to an interview with Sharon Mayl at FDA, FSVP inspections are not to be confused with traditional food facility inspections and consist of a document review. This review may examine whether an importer has detailed components required under the FSVP rule for the specified suppliers and food items. The inspector may also look for evidence that FSVP procedures are followed between importer and supplier for the food items in question and that the importer is documenting appropriate analyses and verification activities, reviewed by a Qualified Individual.
Registrar Corp’s Regulatory Specialists can assist in developing appropriate FSVPs for your food items. Additionally, Registrar Corp’s FDA Compliance Monitor can monitor suppliers’ compliance history as required under the rule and can serve as proof of compliance during a FDA FSVP inspection.
Registrar Corp assists food and beverage companies with FDA compliance. For more information or assistance with specific FSVP requirements, please call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.