FSMA Two-Tier Inspections - Notice to Industry

The Food and Drug Administration (FDA) is soliciting businesses with multiple food processing facilities that implement centrally-developed [1] supply-chain programs and recall plans to volunteer for two-tier inspections. For participating facilities, FDA will assess the adequacy of the supply-chain program (subpart G of part 117) and recall plan (21 CFR 117.139) in a single Tier 1 inspection. FDA will then assess implementation of the supply-chain program and compliance with other applicable requirements in part 117 during separate Tier 2 inspections. 

FDA will consider the results of this two-tier inspection approach to:

• determine the feasibility of using this approach on a broader scale
• develop and refine an internal process for FDA to implement this inspection approach in the future if deemed worthwhile, and
• obtain data on inspection efficiency when centrally-developed programs are assessed at one facility rather than at multiple facilities.

The potential benefits of the two-tier inspection 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.

FDA will share the general outcome from this approach.

TWO-TIER APPROACH:

The two-tier approach is comprised of two assessments, or tiers.

Tier 1 inspections:

• Will assess adequacy of the written supply-chain programs and recall plans and compliance with all applicable requirements in part 117
• Will be pre-announced, focused Preventive Controls for Human Food (PCHF) inspections that are conducted preferably at a facility in close proximity to corporate headquarters, to facilitate engagement between FDA and key company individuals who are knowledgeable about the preventive control programs and the basis for those programs
• Will be used to inform Tier 2 inspections

Tier 2 inspections:

• Will assess compliance with all applicable requirements in part 117 except for the adequacy of written supply-chain programs and recall plans that were reviewed during the Tier 1 inspection
• Will be unannounced and occur after a Tier 1 inspection

CRITERIA TO PARTICIPATE:

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., compliance date is in effect), and
• Have a required supply-chain program and recall plan that have been centrally-developed

HOW TO CONTACT FDA IF INTERESTED IN PARTICIPATING:

FDA intends to limit initial participation to approximately five (5) businesses with centrally-developed programs and a minimum of two (2) related facilities within each business. Participant selection will be based on the total number of facilities implementing the centrally-developed programs and the categories or types of products at each facility requiring a supply-chain program and recall plan. Not all interested businesses may be selected.

Businesses that satisfy the “Criteria to Participate” and wish to participate in a two-tier inspections approach should send an email expressing their interest to FDA at: TwoTierInspections@fda.hhs.gov by 10/31/2018.

Emails to FDA should include the names, addresses, and contact persons for each business interested in participating, the facility that would participate in the Tier 1 inspection, the facilities available for Tier 2 inspections, the number of facilities implementing the centrally-developed programs, and the categories or types of products at each facility. FDA will notify applicants if they have or have not been selected using the contact information that is provided. 

[1] “Centrally developed” in this context means established at a business or corporate level for multiple facilities  within the business entity.