IHS Chemical Week

EnviroTech :: Regulatory :: Regulatory: Legal

FDA Issues Warning Letter to Lonza Plant in U.S.

1:21 AM MDT | September 14, 2011 | Deepti Ramesh

The U.S. Food and Drug Administration (FDA) issued a warning letter earlier this month to Lonza’s manufacturing plant at Hopkinton, MA, for deviating from current good manufacturing practice (cGMP). An FDA inspection from April 4, 2011 to May 6, 2011 at Lonza’s pharmaceutical and active pharmaceutical ingredient (API) manufacturing facility at Hopkinton identified significant violations of cGMP regulations for finished pharmaceuticals, and from cGMP for the manufacture of APIs, FDA says. Lonza responded on May 26, 2011 and the FDA says it has reviewed...

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