FDA to China: Prime Suspect Is Heparin Contaminant
According to the AP, the FDA said yesterday that there is a “solid link” between the hundreds of allergic reactions and now 81 deaths associated with Baxter’s recalled heparin and a contaminant, identified as oversulfated chondroitin sulfate. The FDA statement is a response to a Chinese official’s claim that the contaminant could not be the source of the adverse reactions, because some batches of the implicated heparin did not contain it. The FDA also responded that this claim is based on false assumptions.
Baxter’s heparin supplier, Wisconsin-based Scientific Protein Labs, said in related news, “It is now clear that the suspect contaminant was introduced earlier in the supply chain in China and was widespread throughout the unrelated Chinese supply chains of many companies.” SPL owns a Changzhou plant, which buys its crude material from Chinese heparin “workshops.” The plant was cited by the FDA in February for a number of “significant deviations” from good manufacturing processes.
The FDA publicly released its warning letter to SPL’s Changzhou facility yesterday, which included the following admonishments:
- There is no assurance that processing steps used to manufacture heparin sodium, USP are capable of effectively removing impurities.
- You fail to have adequate systems for evaluating the suppliers of heparin crude materials, and the crude materials, themselves, to ensure that these materials are acceptable for use.
- Equipment used to manufacture heparin sodium USP is unsuitable for its intended use.