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Expert Analysis

Current Trends In FDA's Good Manufacturing Enforcement

Law360, New York (March 18, 2013, 1:10 PM EDT) -- Drugs and devices are "adulterated," as that term is used in the Food, Drug and Cosmetic Act, if the drugs and devices are contaminated, impure or diluted; deliver too much or too little of the active ingredient; or do not conform to mandatory specifications. A product can also be deemed adulterated — even in the absence of any such defects — if the manner in which the product was manufactured did not conform to the "Good Manufacturing Practice" or "Quality System" regulations (collectively known as the GMP regulations)....

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