FDA Hammers Active Ingredient Maker Over 'Severe Hazard'
Law360, New York (February 12, 2014, 6:13 PM EST) -- A manufacturer of active pharmaceutical ingredients created a "severe hazard" by adopting substandard labeling and storage practices at plants in Arizona and Hong Kong, according to a U.S. Food and Drug Administration warning letter released Wednesday.
In one of the most notable findings, the FDA said that it encountered a container whose labels indicated the presence of an inactive ingredient, but that testing of the contents revealed a variety of different substances used to treat medical conditions.
"The unacceptable practices that resulted in this mislabeling incident can pose a severe hazard to consumers," the FDA wrote to CBSCHEM Ltd.
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