Contaminated vaccines at Merck plant
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Contaminated children's vaccines and other potentially serious concerns were spotted by federal regulators who combed Merck & Co.'s vaccine plant in the Philadelphia suburbs, according to a published report.
Unwanted fibers on vaccine vial stoppers also were among the areas of concern cited by inspectors from the U.S. Food and Drug Administration, The Philadelphia Inquirer reported in Thursday's editions.
Based on an unpublished FDA report the newspaper obtained through a Freedom of Information Act request, the article said inspectors found 49 areas of concern, ranging from failure to follow good management practices to contamination of bulk lots of vaccine.
FDA inspectors visited the plant, in West Point in Montgomery County, on 30 separate days from November through January.
In December, Merck recalled 1.2 million doses of its vaccine against Haemophilus influenza type B, made at the same plant, because of a sterility problem discovered in October. It also quarantined nearly a year's worth of other, possibly suspect doses.
Merck executive John McCubbins, head of Merck's Global Vaccine Manufacturing and West Point operations, told the newspaper no contamination was found in finished vaccines and that the company is addressing the problems.
Unwanted fibers on vaccine vial stoppers also were among the areas of concern cited by inspectors from the U.S. Food and Drug Administration, The Philadelphia Inquirer reported in Thursday's editions.
Based on an unpublished FDA report the newspaper obtained through a Freedom of Information Act request, the article said inspectors found 49 areas of concern, ranging from failure to follow good management practices to contamination of bulk lots of vaccine.
FDA inspectors visited the plant, in West Point in Montgomery County, on 30 separate days from November through January.
In December, Merck recalled 1.2 million doses of its vaccine against Haemophilus influenza type B, made at the same plant, because of a sterility problem discovered in October. It also quarantined nearly a year's worth of other, possibly suspect doses.
Merck executive John McCubbins, head of Merck's Global Vaccine Manufacturing and West Point operations, told the newspaper no contamination was found in finished vaccines and that the company is addressing the problems.
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