FDA May Reinspect Korean Seafood Facility; Apparently 1st Notification of U.S. Agent Fee Liability
The Food and Drug Administration may do a reinspection of Korean seafood processor Shinhan F&B Co.’s facility and assess associated fees, so the company “should consider providing [its] U.S Agent with a copy” of the associated warning letter, it said. The warning letter appears to be the first posted to the FDA website that contains language on U.S. agent liability for reinspection fees. FDA said the facility’s violations of the Seafood Hazard Analysis and Critical Control Point regulation constitute “noncompliance materially related to a food safety requirement of the Act,” and is therefore liable for the fees. FDA also threatened to place the facility’s products on detention without physical examination.
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The language inserted into the letter to address reinspection fees and U.S. agent liability provides a notification that fees may be assessed, and advises the facility to tell its U.S. agent. The relevant paragraph in the warning letter is as follows:
“Additionally, 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 re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance 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 foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. You should consider providing your US Agent with a copy of this letter.”