And so the new cooperation pact with the US Health and Human Services and the FDA begins with a disagreement - Chinese officials are voicing doubts that a contaminant identified in Heparin was the root cause of 81 deaths and severe allergic reactions in hundreds of Americans, theAssociated Press reports.
The officials suggested at an embassy news conference that the problem with the drug could have occurred in the US and plan to visit a Baxter International plant in New Jersey to get a better picture of how the finished product is manufactured. "When you see it, then you believe it," Jin Shaohong, the deputy director general for the National Institute for the Control of Pharmaceutical and Biological Products in China, tells reporters.
Heparin is derived from a mucus obtained from pig intestines and other animal tissues, often processed by small, unregistered workshops in China. Scientific Protein Laboratories owns a Chinese factory - Changzhou SPL - and buys additional raw heparin from other Chinese suppliers. Chinese officials say Changzhou SPL, the manufacturer of the heparin ingredient, was managed and overseen by a manager from Scientific Protein Lab headquarters in Wisconsin, and the manufacturing processes and quality control was all provided by SPL headquarters.
The FDA says 62 deaths are associated with allergic-style reactions to contaminated batches of heparin, but is still uncertain what caused the reactions. The chief suspect, however, is a contaminant that the agency discovered in supplies of raw heparin coming from China.
UPDATE: The FDA just posted on its web site an April 21 letter to Changzhou SPL that details several problems following a recent inspection. Among the findings - There is no assurance that processing steps used to manufacture heparin sodium are capable of effectively removing impurities; No adequate systems exist to evaluate heparin suppliers or crude materials; Test methods performed for heparin sodium USP haven't been verified to ensure suitability under actual conditions of use; And the equipment used to manufacture heparin sodium USP is unsuitable for its intended use.