FDA warns Merck to fix vaccine plant problems [View All]

[Celebration]

yikes.........

http://news.yahoo.com/s/ap/20080430/ap_on_bi_ge/merck_fda

TRENTON, N.J. - The Food and Drug Administration has ordered Merck & Co. to correct numerous manufacturing deficiencies at its main vaccine plant, the latest in a string of setbacks for the drugmaker.

The agency on Wednesday released a warning letter sent to Merck's chief executive, Richard T. Clark, that states FDA inspectors determined manufacturing rules are not being followed at the plant in West Point, Pa., just outside Philadelphia.

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The nine-page letter states FDA 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 issued the warning letter because Merck's response to the FDA report sent after the inspections was "inadequate to address the serious deviations noted."

According to the heavily redacted warning letter, Merck officials didn't thoroughly investigate when vaccine batches inexplicably failed to meet specifications, even if batches had been distributed, and some combination measles-mumps-rubella shots that failed "visual inspection for critical defects" were distributed anyway.