The US Food and Drug Administration (FDA) has found that the Chinese manufacturer of an ingredient in recently recalled lots of heparin products failed to follow adequate safety measures, according to a warning letter sent to the company in April.
The letter was sent to Changzhou SPL Company, Ltd, which made an ingredient used in the production of heparin products made by Baxter International of Deerfield, Ill. In the letter (http://www.fda.gov/cder/warn/2008/320-08-01.pdf), the agency notes that Changzhou failed to follow good manufacturing practices that would prevent contamination; the company had inadequate processes for removing impurities, a lack of verified testing for the products' suitability for use, and unclean equipment. The FDA also said the company had inadequate systems in place to ensure the quality of raw ingredients from outside suppliers. In some cases, materials were used that came from suppliers Changzhou had deemed unsuitable, the agency said.
Kuehn BM. Heparin Deaths. JAMA. 2008;299(20):2379. doi:10.1001/jama.299.20.2379-a