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Markets :: Fine Chemicals/Biotech :: Pharmaceutical ingredients

FDA issues warning letter to API manufacturer in Japan

10:03 AM MDT | April 5, 2013 | Deepti Ramesh

US FDA issued a warning letter late last month to the active pharmaceutical ingredient (API) manufacturing facility of Asada Milling Co. (Kanra, Japan), for deviating from cGMP. An FDA inspection of the Kanra API facility from 9–12 October 2012 identified significant deviations from cGMP for the manufacture of APIs, FDA says. The violations for the manufacture of APIs at the Kanra site include failure to perform quality-control-related activities, failure to maintain and clean manufacturing equipment and facilities, failure to establish written procedures...

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