Increased FDA scrutiny for regulated products from Tianjin, China


On October 27th Customs and Border Protection (CBP) issued an update and reminder on FDA’s increased surveillance of certain FDA regulated products imported from the industrial center Binhai New Area in Tianjin, China AND Xiditou Township of Beichen District in Tianjin, China.

On August 12, 2015 a chemical explosion occurred at the Tianjin Dongjiang Port Rui Hai International Logistics Co., at the industrial center named Bihhai New Area. Tianjin Dongjiang Port Rui Hai International Logistics Co. Ltd. was a storage and distribution center of containers with hazardous chemicals: sodium cyanide (NaCN), toluene diisocyanate (TDI) and calcium carbide (CaC2), all of which pose direct threats to human health on contact. NaCN in particular is highly toxic.

On October 12, 2015, a second explosion occurred at a warehouse owned by Tianjin Yong Sheng Fine Chemical Co., Ltd. at Xiditou Township of Beichen District in Tianjin, China.  The 700 square-meter warehouse, located in the northern suburbs, is reported to have stored about 3,000 kilograms of alcohol, 1,000 kilograms of acetic acid, 800 kilograms of glycerinum, 500 kilograms of sodium hydroxide and 500 kilograms of potassium hydroxide.  Other chemicals that may be associated with the explosion remain unknown.

As of result of these events, FDA has advised that human and animal drug products and medical devices that left the Tianjin, China area on or after August 12, 2015, will require additional information in order to obtain an FDA import release (may proceed).  The agency is requesting importers to submit the following information related to the products they are importing:

  • Provide the name of the end commercial user of the product and identify all known receivers of the items
  • Advise on the physical location of the product between the date of the explosion and when it was exported
  • Describe the packaging that was used for the product (e.g. – primary, secondary packaging, wrapped pallet, shipping container, etc.)
  • Confirm if a risk assessment for the safety of the product was performed? If yes, describe the methodology used
  • Confirm if testing will be performed on the products to determine if there was any contamination

We urge Importers to determine if any of their drug products or medical devices originate from industrial center Binhai New Area in Tianjin, China and/or Xiditou Township of Beichen District in Tianjin, China and be prepared to comply with the FDA’s additional reporting requirements.

For additional information on this matter or questions related to US FDA import compliance, please contact Marken’s Trade Compliance department.

Daniel J Bell

VP Regulatory Compliance & Technical Affairs                                                                                    06 November, 2015

References: CBP CSMS Message #15-000805

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