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FDA Ends Heightened Surveillance of Goods Imported from Tianjin, China

Thursday, July 07, 2016
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has ended its increased surveillance of certain FDA-regulated products imported from the Binhai New Area industrial center in Tianjin, China, and Xiditou Township of Beichen District in Tianjin, China, and has returned to routine surveillance of such goods.

In August 2015 an explosion at a hazardous chemical container storage and distribution center at the port of Tianjin destroyed a significant amount of cargo and port facilities. The FDA subsequently began requiring the submission of entry and shipping documents (bills of lading, air waybills, commercial invoices, etc.) for entries of FDA-regulated goods that originated from, were stored in or transited through the Binhai New Area industrial center in Tianjin. Human and animal food products, human and animal drug products, and medical devices that left the Tianjin area on or after Aug. 12 required additional information to enable the FDA to make admissibility decisions; e.g., the physical disposition of the product at the time of the explosion and for the time between the explosion and when the product left Tianjin, whether the importer conducted a risk assessment to determine the impact of the explosion on the safety of its product, and what testing was conducted on the product to identify contamination associated with the explosion.

The FDA subsequently expanded this requirement to such goods that originated from, were stored in or transited through the Xiditou Township of Beichen District in Tianjin following an Oct. 12 explosion at a warehouse reported to have stored alcohol, acetic acid, glycerinum, sodium hydroxide, potassium hydroxide and possible other chemicals.

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