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FDA issues warning letter to API plant in India

4:06 AM MDT | March 13, 2014 | Deepti Ramesh

FDA issued a warning letter at the end of February 2014 to the active pharmaceutical ingredient (API) manufacturing facility of Canton Laboratories (Vadodara, India) located at Vadodara for violations of cGMP. An FDA inspection from 1-9 April 2013 at the Vadodara API facility identified significant deviations from cGMP for the manufacture of APIs, FDA says. The warning letter was published in the FDA website earlier this week. The violations at the API site include failure to perform laboratory testing of APIs to ensure conformance to specifications and to...

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