IHS Chemical Week

EnviroTech :: Regulatory :: Regulatory: Legal

FDA issues warning letter to Sun Pharma's API plant in India

12:47 PM MDT | May 21, 2014 | Deepti Ramesh

FDA issued a warning letter on 7 May to the active pharmaceutical ingredient (API) and finished pharmaceutical manufacturing facilities of Sun Pharmaceutical Industries (Sun Pharma; Mumbai)—located at Karkhadi, Vadodara District, India—for violations of cGMP. The warning letter was published on the FDA Web site on 20 May. An FDA inspection from 13–16 November 2013 at the Karkhadi facility identified deviations from cGMP for the manufacture of APIs and the violation of cGMP regulations for finished pharmaceuticals, FDA says. An import alert was...

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