IHS Chemical Week

EnviroTech :: Regulatory :: Regulatory: Legal

FDA Issues Warning Letter to Merck KGaA’s API Plant in Switzerland

5:50 AM MST | February 16, 2012 | Deepti Ramesh

The U.S. Food and Drug Administration (FDA) issued a warning letter in December 2011, to the active pharmaceutical ingredient (API) facility at Corsier-sur-Vevey, Switzerland, of Merck KGaA’s Merck Serono (Geneva) division, for deviating from current good manufacturing practice (cGMP). The FDA published the warning letter on its website, earlier this month. An FDA inspection of the Corsier-sur-Vevey API facility from June 1-June 9, 2011, identified significant deviations from cGMP for the manufacture of APIs and significant violations to requirements...

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