FDA Releases New Documentation Requirements for Goods Imported from Tianjin

US importers of human and animal food products, human and animal drug products and medical devices from the Tianjin, China region should be conscious of added regulations from the Food and Drug Administration (FDA) for entries of these goods.

The FDA response to the August explosion inside a hazardous chemical container storage industrial center in Binhai New Area was to expand the submission of entry and shipping documents such as bills of lading, air waybills, and commercial invoices for FDA-regulated goods from the area.

The agency announced that FDA-regulated goods imported from the Xiditou Township of Beichen District in Tianjin will also require additional information for an admissibility decision, following an October explosion at a hazardous chemical warehouse.

The FDA wants to ensure the explosions did not contaminate entries that originated from or transited through either point of origin and will review the submission of entry and shipping documents to determine if the shipment was in the Tianjin, China area on or after August 12, 2015.

To expedite the FDA’s review process, OCEANAIR advises importers to submit entry documentation along with location and availability information promptly. The FDA strongly recommends submitting documents electronically through the agency’s Import Trade Auxiliary Communication System (ITACS) to facilitate receipt and review of information.

Entry of FDA-related human and animal food products, human and animal drug products, and medical devices from Tianjin will require Importers to:

Supply information identifying all known recipients of the product (The end user of the commercial product cannot be the importer).
Provide a physical description and geographic location of the product at the time of the explosions, departure from Tianjin, and the present status. Include the product’s geographical location at the time of the explosions and the packaging information.
Conduct a risk assessment of the safety of the product to determine the impact of the August 12 and October 12 explosions and explain your methodology and the outcome of your assessment
Describe the testing procedures used to identify possible contamination associated with either explosion.
For instructions on how to use ITACS, or for further information about these regulations, please contact the OCEANAIR compliance department, Harvey Waite by phone at (781) 286-2700 (office) or (617) 335-7790 (cell).