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1 mai 2008
F.D.A. Warns Merck About Plant
By THE ASSOCIATED PRESS
The Food and Drug Administration has ordered Merck & Company to correct numerous manufacturing deficiencies at its main vaccine plant, the agency said Wednesday.
The agency released a warning letter sent to Merck’s chief executive, Richard T. Clark, that states its inspectors had determined that manufacturing rules were not being followed at the plant in West Point, Pa., just outside Philadelphia.
The plant, which recalled two vaccines in December over sterility problems, makes a number of children’s vaccines and four for adults.
The nine-page letter states that the agency found "significant objectionable conditions" in the manufacture of vaccines and drug ingredients during repeated inspections from Nov. 26 to Jan. 17.
In a separate posting on its Web site, the agency said it had issued the warning letter because Merck’s response to the F.D.A. report sent after the inspections was "inadequate to address the serious deviations noted."
The F.D.A. said in the posting that it "does not believe that the issues identified will affect the safety of the vaccines" made at West Point, or their availability.
Amy Rose, a spokeswoman for Merck, said, "We’re committed to working with the F.D.A. to ensure that all these issues are addressed to their full satisfaction."
