Member Alerts
Dairy and Infant Formula Product Storage Facility Registration Requirements for New FDA List of Facilities Approved to Export to China
USDEC has received clarification from the U.S. Government regarding FDA's Guidance entitled "Establishing and Maintaining a List of U.S. Milk Product Manufacturers/Processors with Interest in Exporting to China." We have learned Chinese Decree 145 requires that all dairy and infant formula product storage facilities be included in the FDA list of establishments eligible to export to China. 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.
If you have any questions please contact Matt McKnight (mmcknight@usdec.org) or Mitch Bowling (mbowling@usdec.org) at 703-528-3049.