• Three FDA Food Safety Modernization Act (FSMA) rules (Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals) require importers and facilities to evaluate their suppliers’ compliance with food safety laws and the Food and Drug Administration’s (FDA) regulations. FDA created a Supplier Evaluation Resources page that lists multiple FDA databases that can be searched to determine whether a supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety.
  • Last week, a new section was added to FDA’s DATA DASHBOARD to provide a tool for searching multiple databases relevant to supply-chain verification requirements in a single search. Anyone can search by entering all or part of a firm’s name, or the firm’s FDA Establishment Identifier (FEI). Results may return several rows, including many with the same name. Address information can be used to distinguish locations since each company location will display a separate firm profile.
  • We caution, however, that relying solely on the new consolidated search tool to discover relevant information will not likely satisfy importers’ and facilities’ supply-chain verification obligations because the dashboard search encompasses only finalized and completed FDA actions. In addition, it is also not clear whether the databases are comprehensive. For example, the bottom of the “results” page from a dashboard search includes a caveat: “Actions pertaining to foreign firms often take the form of import alerts, and are currently not reported in this Dashboard release,” suggesting the new consolidated search tool does not locate import alerts, which are relevant to evaluating a supplier’s performance and the risk associated with a food under the FSVP and the supplier approval process under the Preventive Controls rules. However, for at least some companies, the search results include Import Alert information under a tab called “Import Alert & Warning Letters.” Regulated companies should use the search tool as one part of their supplier assessment efforts. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about FSMA supply-chain verification requirements.