FDA Issues Chinese Heparin Supplier Warning Letter After Finding Conditions UnsuitableApr 24, 2008 | Parker Waichman LLP
An inspection by U.S. regulators of the Chinese factory that supplied tainted heparin ingredients to Baxter International revealed significant deviations from U.S. Current Good Manufacturing Practice standards. As a result, the Food & Drug Administration (FDA) informed the plant in a warning letter that all future shipments from the Changzhou SPL facility will be refused entry to the U.S. until the factory makes required corrections and the FDA is able to confirm that it is in compliance with Current Good Manufacturing Practice standards.
Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. In March, the FDA confirmed that it had found a counterfeit ingredient, oversulfated chondroitin sulfate, in samples of the active ingredient used in Baxter heparin. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. So far, 81 deaths in the U.S. have been linked to the tainted heparin, and earlier this week, the FDA said it had evidence that the chondroitin sulfate did, in fact, cause the reactions and deaths.
The FDA conducted an inspection of Changzhou SPL in March. According to the strongly-worded warning letter to the factory dated April 21, conditions there were deemed "unsuitable" by the FDA. The agency said that the Changzhou provided no assurance that processing steps used to manufacture heparin ingredients were capable of effectively removing impurities. The letter also stated that Changzhou had acknowledged to the FDA that it received and used heparin crude materials from a workshop that Changzhou itself had deemed as "unacceptable" in a "pre-audit". Even though that workshop was ultimately not approved to be a supplier to the facility, Changzhou used crude material from this workshop in the production of heparin ingredients that were shipped to the U.S.
In addition, the FDA warning letter to Changzhou SPL said that the testing methods employed by the facility were not " verified to ensure suitability under actual conditions of use," and that equipment used at the factory to make heparin ingredients was "unsuitable for its intended use".
The FDA has given Changzhou SPL 30 days to respond to the charges in the letter. Until the FDA is able to confirm that Changzhou has corrected violations at the factory, and certify that it now meets Current Good Manufacturing Practice standards, all products made there will be denied entry to the U.S.