/ Source: The Associated Press
The Food and Drug Administration has told the Chinese manufacturer of a heparin ingredient that it does not have adequate systems for ensuring that the raw materials it uses are safe and that any impurities are removed.
The FDA released a warning letter Monday 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.
