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).

Manufacturers therefore must not only avoid product defects...
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