Many U.S. importers are required to comply with the U.S. Food and Drug Administration (FDA) Foreign Supplier Verification Program (FSVP) rule by May 30, 2017.
Finalized in November 2015 under the Food Safety Modernization Act (FSMA), FDA’s FSVP rule requires “FSVP Importers” to perform certain activities to verify that the food they import is produced in a manner that meets U.S. safety standards. If you are unsure whether you are considered an FSVP Importer, Registrar Corp’s free FSMA Wizard can assist you in determining your potential requirements.
Evaluating and Approving Suppliers
FDA’s FSVP rule requires that FSVP Importers import only from approved foreign suppliers, although they may import from an unapproved supplier on a temporary basis. To approve a supplier, an FSVP Importer must consider the supplier’s compliance with FDA food safety regulations, including whether the supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety.
Comments in the final rule regarding this requirement reflect industry concern that FDA’s website and compliance databases can be hard to navigate. To evaluate a supplier’s compliance using FDA’s website, an FSVP Importer has to search each of FDA’s applicable databases for each individual supplier. Registrar Corp’s FDA Compliance Monitor allows users to easily evaluate food facilities’ FDA compliance statuses. The Monitor compiles data on FDA Import Alerts, Warning Letters, Import Refusals, and Inspection Classifications for a user’s suppliers in a simple dashboard, which also tracks whether suppliers are approved.
FSVPs must be created by a “Qualified Individual,” defined as an individual with the education, training, or experience necessary to perform their assigned activities and the ability to read and understand the language of any records that must be reviewed in performing an activity. An FSVP must include a hazard analysis and appropriate supplier verification activities to provide assurance that these hazards will be significantly minimized or prevented. Examples of supplier verification activities include audits, records review, and sampling and testing.
What qualify as “appropriate” verification activities for a particular supplier depends on the types of foods being imported and the supplier’s compliance history. Registrar Corp’s Food Safety Specialists act as Qualified Individuals and can develop or review FSVPs to ensure they are appropriate for your specific needs.
Should an FSVP Importer become aware of non-compliance by one of its approved suppliers, the importer must ensure corrective action is taken. Registrar Corp can assist in implementing corrective actions. For example, action taken to have a foreign supplier removed from import alert may be considered an appropriate corrective action. Registrar Corp can help facilities create and submit a petition to FDA for removal from import alert. Additionally, labeling errors are one of the largest causes for warning letters and detentions. Registrar Corp can review food labeling and ingredients for FDA compliance.
This article was originally published as a press release.