IHS Chemical Week

Markets :: Fine Chemicals/Biotech :: Pharmaceutical ingredients

FDA Issues Warning Letter and Import Alert on AkzoNobel’s API Plant in Mexico

2:22 AM MST | December 12, 2011 | Deepti Ramesh

The U.S. Food and Drug Administration (FDA) issued a warning letter last month to Akzo Nobel Chemicals’ (Los Reyes La Paz, Mexico) manufacturing plant at Los Reyes La Paz, for deviating from current good manufacturing practice (cGMP). An FDA inspection in June 2011 at the AkzoNobel active pharmaceutical ingredient (API) manufacturing facility at Los Reyes La Paz identified significant deviations from cGMP for the manufacture of APIs, FDA says. AkzoNobel responded on July 11, 2011 and the FDA says it has reviewed the response, and that the corrective actions...

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