'Show' and 'Shadow' Heparin Facilities Targeted in Pair of FDA Warning Letters
This article was originally published in The Gold Sheet
FDA issued heparin-related warning letters last month to two Chinese API suppliers - one for posing as a heparin API supplier, and the other for supplying adulterated heparin to the U.S. in violation of cGMP requirements
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One pilot target domestic manufacturers of finished drugs and another foreign manufacturers of APIs. As an incentive to participate, companies assigned high scores will be accorded regulatory flexibility. Also, participants that disclose facility ratings could “benefit from a competitive advantage.”