Late yesterday, Baxter International ordered a full-scale recall on the blood thinner Heparin. Up to 21 people now may have died and hundreds have suffered adverse reactions from the Baxter made product. A recall was put off until now, due to concerns over a shortage.
FDA officials said at a news conference yesterday that they had inspected the Chinese facility that provided the active ingredient to Baxter, although things are still unclear:
Among the potential problems they found was a failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment. According to a redacted inspection report released by the agency, the SPL plant appeared to have made at least some heparin with “material from an unacceptable workshop vendor.” The vendor was not identified.
And this inspection came a little too late:
The F.D.A. admitted this month that it had violated its own policy by failing to inspect SPL, located west of Shanghai, before the factory began shipping the heparin ingredient to Baxter in 2004. China’s drug agency also did not inspect the plant.
Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research admitted to Congresswoman Rosa DeLauro (D-CT) at a hearing Wednesday that the FDA only inspects about 10% of the foreign facilities shipping drugs and ingredients into the US.