FDA Scolds Merck About Conditions At Pa. Plant

Law360, New York (May 1, 2008, 12:00 AM EDT) -- Following a nearly two-month inspection of a Merck & Co. Inc. plant in Pennsylvania, the U.S. Food and Drug Administration sent the company a warning letter this week outlining what it calls “significant objectionable conditions” at the plant.

The violations are described by the FDA as “inadequate investigations of deviations and failure to maintain production and process controls,” including instances in which unnecessary fibers ended up in vaccine vials.

Nevertheless, the FDA says on its Web site that it “does not believe that the issues identified...
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