FDA Warns AMRI Over Contamination At Mass. Plant

Law360, New York (August 24, 2010, 1:57 PM EDT) -- The U.S. Food and Drug Administration has warned Albany Molecular Research Inc. about “adulterated” drugs it discovered at one of the drugmaker's plants during an inspection.

FDA representatives found particulate contamination in samples of AMRI's injection drugs and saw employees using potentially nonsterile gloves and garments at the company's Burlington, Mass. manufacturing facility, the agency said in an Aug. 17 letter.

These “significant violations” of manufacturing regulations for finished pharmaceuticals caused the products at issue to be “adulterated” under the Federal Food, Drug, and Cosmetic Act,...
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