FDA Proposal Requires Verification of Foreign Facilities Via U.S. Agent, Requests D-U-N-S Numbers for Each Facility

As IWLA carefully combs through the U.S. Food and Drug Administration’s latest proposal it brings up a few very important issues to the surface.

According to IWLA Washington Representative Pat O’Connor:

Foreign Facilities and Designation of Agents:  The FDA proposes that a foreign facility’s registration will not be confirmed until the designated U.S. agent confirms to FDA that it has agreed to serve as U.S. agent.  This will address the concern that IWLA has raised with respect to the Foreign Supplier Verification Program.

Excerpt from the proposed rule: “Proposed § 1.231(a)(5) and (b)(7) would provide that after a foreign facility completes its registration or updates its U.S. agent information as part of registration renewal, FDA will email the person identified as the U.S. agent for the foreign facility, using the email address for the person identified as the U.S. agent in the facility’s registration, to verify that the person has agreed to serve as the facility’s U.S. agent. FDA would not confirm the foreign facility’s registration or registration renewal until that person confirms that the person agreed to serve as the U.S. agent for the foreign facility.”

D-U-N-S:  FDA proposes to require and verify the D-U-N-S number for each facility. Excerpt: “FDA would not confirm a food facility’s registration or registration renewal until FDA verifies the accuracy of its D–U–N– S® number and verifies that the facility- specific address associated with the D– U–N–S® number is the same address associated with the facility’s registration.” This will requirement assumes that a D-U-N-S number is typically acquired for each facility location. However, that is not always the case. IWLA will likely issue comments on this in the near future.

Activity Conducted at the Facility: The FDA proposes that the type of activity conducted at the facility for each food product category be identified. Excerpt:  “Would require facilities to choose among the following activity types: (1) Ambient human food storage warehouse/holding facility; (2) Refrigerated human food warehouse/ holding facility; (3) Frozen human food warehouse/holding facility; (4) Interstate conveyance caterer/catering point; (5) Contract Sterilizer; (6) Labeler/Relabeler; (7) Manufacturer/ Processor; (8) Farm Mixed-Type Facility; (9) Packer/Repacker; (10) Salvage Operator (Reconditioner); (11) Animal food warehouse/holding facility; and (12) Other Activity.

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