Background

The Food and Drug Administration is soliciting businesses with multiple food processing facilities that implement centrally-developed supply chain programs and recall plans to volunteer for two-tier inspections.

For participating facilities, FDA will assess the adequacy of written supply-chain programs and recall plans as well as compliance with all applicable requirements in 21 CFR Part 117 in a single Tier 1 inspection. Such inspections will be pre-announced, focused on preventive controls for human food, and conducted preferably at a facility in close proximity to corporate headquarters to facilitate engagement between the FDA and key company individuals who are knowledgeable about the preventive control programs and the basis for them. The FDA will then use the results of the Tier 1 inspections to inform Tier 2 inspections, which will be unannounced and assess the implementation of supply chain programs and compliance with other applicable requirements under part 117.

The FDA states that the potential benefits of this approach are decreased inspection time in facilities, improved public health protection by addressing food safety issues across multiple facilities, and greater opportunities for education, outreach, and communication between FDA food safety staff and industry. The agency will consider the results of this initial program to determine the feasibility of using this approach on a broader scale.

Businesses that volunteer to be inspected under the two-tier inspection approach should have two or more domestic registered food facilities that are now subject to the PCHF rule (i.e., the compliance date is in effect) and have a required supply chain program and recall plan that have been centrally-developed.

For more information or assistance participating in this program, please contact Shelly Garg at (305) 394-1043.

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