WASHINGTON — The Chinese manufacturer of a heparin ingredient does not have adequate systems for ensuring that the raw materials it uses are safe and that any impurities are removed, the Food and Drug Administration told the company Monday.
The FDA released a warning letter to Changzhou SPL Co., hours after Chinese officials voiced doubts that a contaminant identified in the blood thinner heparin caused severe allergic reactions in hundreds of U.S. patients.
The FDA told Changzhou SPL that it had “significant deviations” from good manufacturing processes. Until it complies, the agency will recommend disapproval of any new applications listing the company as the manufacturer of any active pharmaceutical ingredient.
Raw heparin is derived from pig intestines, often processed by small, unregistered workshops in China. Heparin is commonly used before certain types of surgery to prevent dangerous blood clots.
Kidney patients also take it before undergoing dialysis.
The raw ingredient for Baxter International’s recalled heparin came from Wisconsin-based Scientific Protein Laboratories, which in turn owns a Chinese factory — Changzhou SPL — and buys additional raw heparin from other Chinese suppliers.
The company said that it regretted the FDA’s decision and that it did not believe the warning letter reflected Changzhou SPL’s actual state of compliance.
