A mix-up with similar names meant the FDA did not inspect a Chinese plant that makes the active ingredient in the heparin products linked to a recent spike in adverse events.
The mix-up wasn’t discovered until recently and an FDA inspection team is now headed to China to remedy the lapse, FDA officials said today in a press conference.
In principle, a foreign plant that makes an active pharmaceutical ingredient for use in products sold in the U.S. is inspected before the product is approved, said Joseph Famulare, deputy director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research.
But if the plant has been recently inspected for another product, the agency may rely on paperwork from the previous inspection, Famulare told reporters.
The Changzhou SPL plant in China, which makes the active ingredient in Baxter Healthcare’s multiple-dose vials of heparin sodium, had not been inspected and should have been, Famulare said.