The Quality Lowdown: Import Alert Update
Crude heparin supplier Yibin Lihao headlines list of facilities in 12 countries added to the US FDA’s drug GMP import alert.
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US investigators fan out to non-China inspection priorities and Secretary Azar talks supply management; warning letters hit record keeping, investigations and basic GMP compliance.
The FDA must explain how it will prevent heparin adulteration as a virus kills pigs in China again.
Even API from complex plant and animal sources must have impurity specifications under the ICH Q7A guidance, FDA tells Changzhou SPL in warning letter. The firm, which supplied Baxter with contaminated heparin API linked to numerous adverse reactions and deaths, should have done a better job testing the heparin and evaluating suppliers, FDA said