If you are a Food Importer, now is the time to begin to preparations for an FDA inspection to ensure you are compliant with new requirements under U.S. Food and Drug Administration’s (FDA) Foreign Supplier Verification Program (FSVP) rule. The FSVP rule requires importers to:
- Designate a “Qualified Individual” to develop an FSVP for each food imported from each supplier.
- Monitor their foreign suppliers’ FDA compliance.
OCEANAIR’s partner for FSVP related matters is Registrar Corp., a provider of solutions in regards to meeting FDA compliance. Registrar Corp. does not have an affiliation with the FDA. The company’s Food Safety Specialists are Qualified Individuals who can help importers adequately prepare their FSVPs. Registrar Corp. also provides an online tool, the FDA Compliance Monitor, which allows importers to monitor their suppliers per FDA requirements continuously. OCEANAIR and Registrar Corp. are aware that the first round of notices to Food Importers from the FDA have already begun. If you receive an email with the subject line: “FSVP Inspection Requirements, Handouts & Law,”it is a notification that the FDA intends to inspect the Importer for compliance with the FSVP rule.
According to Sharon Mayl, an FDA Senior Policy Advisor, FSVP inspections are not to be confused with traditional food facility inspections and are primarily based on the review of records. The inspector may also look for evidence on whether the relationship between importer and supplier are adhering to FSVP procedures for the food items in question, and if the importer is documenting appropriate analyses and verification activities. Mayl expressed that most FSVP inspections will take place at the importer’s place of business. For further assistance regarding the FSVP rule, please contact Registrar Corp. by phone at +1-754-224-0177, or at the email link below. Additional support is available from Registrar Corp.’s 19 international offices, and the company offers 24-hour live online help on its website.