In a letter sent to Changzhou SPL Co., the Chinese manufacturer of an ingredient found in heparin, the Food and Drug Administration warned that the company did not have proper methods of ensuring that impurities are removed from the controversial blood-thinning drug.
The letter was released just hours after Chinese officials announced that they doubted the contaminant, known as oversulfated chondroitin, was the root cause of several allergic reactions in U.S. patients.
The FDA told Changzhou SPL that the agency will recommend disapproval of any new applications listing the company as the manufacturer of any active pharmaceutical ingredient due to “significant deviations” from good manufacturing processes.
The ingredient under scrutiny was discovered after Baxter International voluntarily recalled several lots of multi-dose vial heparin coming from Wisconsin-based Scientific Protein Laboratories, which also owns Changzhou SPL.
The company said it regretted FDA’s decision and that it did not believe the warning letter reflected Changzhou SPL’s actual state of compliance with good manufacturing practices.
Meanwhile, Chinese officials announced at an embassy news conference that the problems could have originated in the United States. They also plan to visit the Baxter International plant in Cherry Hill, N.J., to further investigate the issues caused by heparin products.
“When you see it, then you believe it,” said Jin Shaohong, the deputy director general for the National Institute for the Control of Pharmaceutical and Biological Products in China.
He added that many batches of recalled heparin have also caused adverse reactions in patients.
“The oversulfated chondroitin can therefore not be a suspected root cause of heparin adverse events as reported in U.S. media previously,” Shaohong said.
“We do not agree with that,” said Baxter spokeswoman Erin Gardiner. “We have seen adverse event reports on batches where the contaminant has been confirmed to be present.”
The FDA has confirmed 62 deaths due to allergic reactions to recalled lots of heparin, although they add that they are unable to link the reactions to a specific ingredient. It is assumed that the contaminant discovered in supplies of raw heparin coming from China is the root cause.
Gardiner added that Baxter would consider allowing Chinese officials to conduct investigations on its heparin samples.
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