FDA update June 8, 2012


Last year, Congress gave the FDA the ability to charge companies for “reinspection” (after the issuance of a W/L) but till now we have not seen any indication when the FDA was planning to use this authority. (see FDA Update – March 5, 2011).

That was till recently. In a warning letter issued this June, to a foreign nutritional supplement company, we observed the following paragraph:

Further, 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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic 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 reinspection-related costs.

So, now warning letters can have a double hit on companies that are issued one:

  1. Your products maybe prevented from entering the USA via import alert or being put on the DWPE (detention without physical examination) list.  This will undoubtedly result in lost revenues to the company.
  2. The FDA may decide to charge you for the reinspection to allow you to have the       warning letter lifted so you can start shipping products again.

The FDA is starting to play “hardball” with the industries they regulate, especially the foreign companies. Assuring you are in full FDA compliance is the best way to proceed, to avoid all these possible financial headaches.

If you would like to discuss the FDA regulatory strategy and what it can mean to you please contact us at info@mdiconsultants.com and ref: FDA “fees for re-inspection”