FDA Saw Problems At Vaccine Plant In 2003
10/19/2005 5:12:14 PM
The Food and Drug Administration (news - web sites) said it was taken by surprise when the U.S. supply of flu vaccine was cut in half in October. Democratic lawmakers said the agency should have seen it coming. Documents provided by the FDA (news - web sites) to a congressional committee show that inspectors uncovered contamination and unsanitary conditions at a Chiron Corp. flu vaccine manufacturing plant in England in 2003. Yet the agency did not re-inspect the facility until similar problems caused the loss of roughly 50 million flu shots destined for the United States.
Acting FDA Commissioner Lester Crawford said the 2003 problems and those that tainted this year's vaccine were unrelated. "The proof of that is that the 2003 vaccine production was completed on schedule and none of it was condemned," Crawford told the House Government Reform Committee (news - web sites) at a hearing Wednesday.
FDA inspectors who visited the Liverpool plant in June 2003 found records of bacteria concentrations a thousand times the expected level, said a report distributed by committee Democrats.
The preliminary inspection report from last month indicates in three places that deficiencies found in 2003 had not been corrected.
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