Warning Letters Begin Addressing FSMA Reinspection Fees

April 9, 2012

By Ricardo Carvajal

Warning letters issued by FDA since late February provide an indication of the types of violations that could trigger reinspection fees under the authority provided by the Food Safety Modernization Act (“FSMA”).  As we noted in a prior blog posting, FSMA authorized FDA to collect fees for a reinspection after a previous inspection that was classified as Official Action Indicated (meaning that significant objectionable conditions or practices were found and regulatory action is warranted to address non-compliance), and where non-compliance was materially related to food safety requirements (meaning the food is adulterated under FDC Act § 402 or misbranded under § 403). 

Warning letters to firms subject to reinspection fees now include the following notice:

Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any costs related to re-inspection.

Thus far, the above notice has been included in warning letters issued for alleged violations of requirements applicable to seafood HACCP, acidified foods, food allergen labeling, animal drug residues, and sanitation and pest control (see, e.g., here and here).  Given the broad range of circumstances under which reinspection fees could be assessed, firms would be well advised to manage their inspections and follow-up corrective actions accordingly.