Also Monday, the FDA issued a warning letter to the Changzhou SPL Company Ltd., which supplies heparin to Baxter International, stating that its manufacturing equipment was "unsuitable for its intended use" and that the company did not adequately scrutinize its own suppliers.
Changzhoi and its parent company, Scientific Protein Laboratories (SPL) of Waunakee, Wisc., expressed "regret" at the FDA's warning letter. "We do not believe that the warning letter reflects Changzhou SPL's actual state of compliance with current good manufacturing practices in the heparin Active Pharmaceutical Ingredient (API) industry, or the positive findings in prior third-party audits of the facility... Changzhou SPL is committed to cooperating with FDA and will promptly provide a detailed response to the warning letter," SPL said in a prepared statement.
The statement added that the contaminant found in certain lots of heparin was not introduced in the manufacturing processes at Changzhou SPL or at SPL, but earlier in the supply chain.
There have been no reports of adverse events in the other countries that turned up contaminated heparin: Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands and New Zealand, the FDA said.
Most of the reactions in the United States have taken place at hemodialysis centers, almost exclusively involving kidney patients receiving a "bolus dose," which is a high dose of heparin administered over a short period of time, according to the FDA.
Despite identification of the contaminant at 12 Chinese companies, FDA officials stressed that they don't know where in the supply chain the oversulfated condroitin sulfate may have been introduced.
And not all contaminated Heparin emerged from Baxter International, Woodcock said.
But FDA officia
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