Compliance Management

FDA Adds Three Chinese Pharma Companies to Import Alert Lists

Source: RAPS

Apr 13, 2016

According to RAPS, three more Chinese pharmaceutical companies were added to two U.S. Food and Drug Administration (FDA) import alert lists this week for failing to meet GMP standards of FDA and for refusing an FDA inspection.

FDA added Xinxiang Pharmaceutical Co. and Xinxiang Tuoxin Biochemical Co., noting: “Only drug and drug products (i.e. adenosine, choline, uridine, uracil, cytidine, inosine, and all pharmaceutical intermediates) are subject to DWPE [Detention Without Physical Examination] under this notice.”

Both companies received FDA Form 483s in 2015, as did Guangzhou Haishi Biological Technology Co., which was also added to the cGMP alert list on March 14, 2016, the article said.

There are now 44 Chinese companies on the list. Read the full story