Baxter Didn't Know About Absence of Inspection
News reports indicate that Baxter didn't monitor its Chinese manufacturer of the active ingredient in the questionable batch of heparin syringes, that have resulted in multiple deaths and hundreds of complaints of allergic reactions to the heparin. The heparin was made from an active ingredient imported from China, but the plant where this ingredient was made was never inspected by the FDA.
Baxter International Inc. CEO Robert Parkinson admitted this week that a combination of factors resulted in this plant not being inspected by the FDA until this week. Baxter stopped manufacturing the product last week. Among those factors are that Baxter didn't import the active ingredient itself, but thru a Wisconsin based company, Scientific Protein Labroratories, based in Waunakee, WI. The active ingredient was actually produced in Changzhou, China. The plant which was co-owned between Scientific Protein and its Chinese Joint Venture partner, never was inspected because some confusion over the name.
This issue of bureaucratic malfeasance, and failure to properly trace all of the active ingredients in a product sold by an American company that is manufactured outside the control of American laws, labor rules and health regulations, is an endemic to the current mood of the huge growth in component import of what appear to be American made products.
Unless the standards for production of these components (such as the active ingredient in heparin or the paint on child's toys) changes, the calls for American only products will grow louder and the shrill cry of American protectionism against imports may become a catalyst to the growing interdependence of world economy.
Is the lead paint and the heparin debacle, just a tip of the iceberg here? Is this the result of 7 years of handsoff regulation from the Bush administration? Can our products ever be reasonably safe again?
Next: German Heparin Also Contaminated
Gordon Johnson is the Owner of the Johnson Law Office.
