Again, these quotes are from the April 29, 2008, House Subcommittee on Oversight and Investigations hearings, see: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml
Regina T. Brown, FDA Consumer Safety Officer was the FDA Officer at the Changzhou SPL plant. U.S. Representative, Jan Schakowsky’s, questioning of Brown included the following with respect to the substandard equipment:
Question by Rep. Schakowsky: You found that the equipment SPL used to manufacture heparin may not have been suitable for its intended use, isn’t that correct?If Brown was describing the conditions of a commercial kitchen, this would be a serious area of concern. But that such non-sterile conditions could occur in the manufacture of an intravenous medicine to be given to ill people, is simply outrageous. Baxter claims to have inspected this plant in the months before word of this calamity reached the U.S. market. It is hard to imagine how an honest inspection could have been done by Baxter, in light of what the FDA inspection showed.
Answer by Brown: Yes.
Q: And how was it unsuitable and why is this important?
A. There were three different pieces of equipment that I found unsuitable for use.
The first was these big polyethylene tanks that they dissolved heparin up in, just prior to the last manufacturing step, which was a liofolization, a freeze drying step. And these PE tanks were scratched on the bottom, very scratched, as if somebody had been chopping stuff out of them with plastic. I ran my fingernail along it and it was like playing an accordion. And there also was stuff adhering to the bottom of these tanks.
Q: This was inside?
A: On the inside of the tanks where crude heparin would be right before it became heparin API. So I scratched stuff off the inside of the tank. And this was tank that was marked clean.
A second PE tank I turned over and liquid fell out of the handle, the molded, PE comes from a mold polyethylene, and stuff, a liquid fell out of the handles into the bottom of the tank. And it was marked cleaned. So it wasn’t a clean tank.
Q: Stuff. Do we know what stuff was in there?
A: The stuff I scratched off? No I don’t know what it was. It was a little gray colored, it wasn’t white. That is all I know.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
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