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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GSK recalls two lots of Children's Robitussin DM and one lot of Children's Dimetapp found to include incorrect dosing cups. Chinese firm Bingbing Pharmaceutical recalls 456,760 lidocaine patches due to the loss of product manufacturing records and product samples.
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.