FDA Sends Alert After Finding Contamination of Drugs by Tianjin Port Explosion
The Food and Drug Administration alerted drug compounders and manufacturers of the continued risk of chemical contamination for shipments from Tianjin, China, following the rejection of two shipments of drugs after finding them contaminated with hydrogen cyanide. According to FDA’s Dec. 22 release (here), the agency’s increased surveillance following two explosions at the Port of Tianjin in August resulted in the detection of the contamination in shipments of drugs from Tianjin Tianyao Pharmaceuticals Co., Ltd. As a result, the contaminated shipments were stopped and “will not be allowed into the United States, said FDA.
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
Testing did not detect hydrogen cyanide in other U.S.-bound shipments of drugs by Tianjin Tianyao since the explosion, and those shipments were released, said FDA. Tianjin Tianyao’s facility is located about 18 miles from the explosion site. FDA implemented additional screening and documentation requirements in early September for shipments regulated by the agency, including foods, drugs and devices, that originated from, were stored in, or transited through the affected area in the Port of Tianjin (see 1509140012). More than 40 different types of chemicals were discovered at the blast site, it said.