FDA found concerns at Merck vaccine plant

[ensho]

http://news.yahoo.com/s/ap/20080424/ap_on_he_me/merck_fda;_ylt=AseQlO76kw9EnFviKv7iB32s0NUE


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Based on an unpublished FDA report the newspaper obtained through a Freedom of Information Act request, the article said inspectors found 49 areas of concern, ranging from failure to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.

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In trading Thursday, Merck shares rose $1.35, or 3.5 percent, to $39.97, near the bottom of their 52-week range of $36.82 to $61.62.
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words fail

[ensho]

1. how strange that DUers are not interested in this

nt

[Hekate]

2. Kick it