Letter to FDA Regarding Fraud Concerns in China, Possible U.S. Heparin Shortage


Excerpt: “We write today to forward information for FDA’s further review and action, as appropriate, related to inconsistencies and red flags in Chinese heparin export and import data that could impact the U.S. heparin supply. The areas of concern relate to the following: (1) whether the Chinese heparin supply is in fact shrinking or increasing, which could affect the risks of a heparin shortage in the U.S. and could raise the risk of economically-motivated adulteration; (2) whether Chinese customs data accurately reflect Chinese heparin export and import activity; and (3) whether the recent emergence of significant U.S. heparin imports to China is further constraining the U.S. domestic supply of heparin.”

To read a copy of the letter, click here.

To read a copy of FDA’s response, click here.