The U.S. Food and Drug Administration confused the name of a Chinese factory that made the tainted blood-thinning drug Heparin with another factory, an error that prevented the inspection of the right facility and resulted with 300 people experiencing deadly allergic reactions. The factory was also not inspected by Chinese regulators. The Chicago Tribune reports on how the Chinese and the FDA are trying to come up with an agreement on how regulate factories that produce pharmaceuticals for the U.S.
The FDA’s explanation, by Joseph Famulare, deputy director of compliance for the FDA’s center for drug evaluation and research, comes amid questions about the safety of different types of goods made in China and the adequacy of the FDA’s inspection procedures for drugs entering the U.S. from China.
More than 300 people have reported potentially deadly allergic reactions after taking the blood-thinning drug heparin, which includes a key active ingredient produced in China for Deerfield-based Baxter International Inc. by Scientific Protein Laboratories of Waunakee, Wis.
While the cause of the allergic reactions remains unknown, the FDA said it plans to visit the Chinese plant this week as part of an investigation that the agency on Monday deemed “one of its top priorities.”
