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FDA issues warning letter to Boehringer Ingelheim API plant

10:14 AM MDT | May 22, 2013 | Deepti Ramesh

FDA issued a warning letter earlier this month to the active pharmaceutical ingredient (API) and finished pharmaceutical manufacturing facility Boehringer Ingelheim (Ingelheim am Rhein, Germany) at Ingelheim am Rhein for violations of cGMP. An FDA inspection of the facility from 5–12 November 2012 identified significant violations of cGMP for the manufacture of APIs and the cGMP regulations for finished pharmaceuticals, FDA says. The warning letter was published in the FDA website on 21 May. The violations for the manufacture of APIs at the Ingelheim am...

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