Member Alerts

Additional Guidance: Product Storage Facility Registration for China

FDA contacted USDEC and asked that we distribute the following additional guidance regarding dairy product storage facility registration. First and foremost, we were told that several companies submitted incomplete information. FDA will not be able to process incomplete applications, and therefore, they have asked that the following information be submitted ON COMPANY LETTERHEAD AS AN ATTACHMENT to Esther Lazar (Esther.Lazar@fda.hhs.gov):

  • Business name and address;
  • Name, telephone number and email (if available) of contact person;
  • List of products presently stored that may be shipped to China and those intended to be stored and shipped;
  • Name and address of the storage facility for each product;
  • Name of any federal, state or local governmental agencies that inspect the facility, along with the government assigned Facility Establishment Identifier (FEI) number and date of last inspection;
  • Copy of last inspection notice and, if other than an FDA inspection, copy of last inspection report.  

FDA has extended the application deadline until close of business March 14, 2014. Additionally, USDEC would like to remind all of our members that FDA has also issued guidance on registration of manufacturing facilities with interest in shipping to China. All companies intending to ship products to China should complete the steps outlined in the FDA guidance.  

If you have any questions, please contact Matt McKnight (mmcknight@usdec.org) or Mitch Bowling (mbowling@usdec.org) at 703-528-3049.