The U.S. Food & Drug Administration (FDA) has announced guidance and requirements pertinent to their intended increased surveillance of certain FDA-regulated products imported from the industrial center Binhai New Area in Tianjin, China. This announcement came via U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service (CSMS) 15-000688. (Note: 15-000688 was issued to correct certain information in the initial message, 15-000676.)
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.
In order to verify the products are not contaminated from the explosion, FDA will be requiring submission of entry and shipping documents (bills of lading, air waybills, commercial invoices, etc.) for entries of human and animal food products, human and animal drug products, and medical devices which are indicated as having originated from, stored in, or transited through the industrial center Binhai New Area in Tianjin, China. FDA will review the documents to determine if the shipment was in the Tianjin, China area on or after August 12, 2015. Products that left the Tianjin, China before August 12, 2015 should need no additional review other than the routine FDA admissibility review.
Additional important requirements and their details are reflected in CSMS 15-000688.
Questions regarding this action by FDA can be directed to Division of Import Operations, 12420 Parklawn Drive, ELEM Room 3109, Rockville, MD 20857
Telephone: (301) 796-0356.
Questions about this regulatory update may be directed to Livingston’s FDA Compliance team, or to the U.S. Regulatory Affairs group.