The FDA has launched a “far-reaching investigation” of a Chinese firm, Changzhou SPL, which made the active pharmaceutical ingredient (API) for Baxter, Michael Rogers, director of the FDA’s Division of Field Investigations, said. Two FDA inspectors were sent to China to carry out that investigation and related investigations of two “consolidators” associated with the API manufacturer. They also may inspect workshops and farms associated with the manufacture of the product, which uses pig intestines.
The agency has posted on its website a redacted version of the Form 483 observations that its investigators issued after inspecting the API plant. It can be accessed at www.fda.gov/ora/frequent/483s/Changzhouspl_heparin_20080226_483.html.
It's the backdoor method of the Chinese trying to kill us. Just kidding. Seriously though this recall does affect the hospitals where I work pretty severely. When do you think we'll stop relying on foreign countries to make a medicine that can be trusted?