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FDA issues warning letter to Smruthi Organics’ API plant in India

2:36 AM MDT | March 26, 2014 | Deepti Ramesh

FDA issued a warning letter earlier this month to the active pharmaceutical ingredient (API) manufacturing facility of Smruthi Organics (Solapur, India) located at Solapur, for violations of cGMP. An FDA inspection from 15–18 October 2013 at the Solapur facility identified deviations from cGMP for the manufacture of APIs, FDA says. The warning letter was published in the FDA Web site earlier this week. The FDA has conducted a detailed review of Smruthi's 4 November 2013 response, but it lacks sufficient corrective actions, FDA says. The violations at the...

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