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FDA tightens control over India’s API manufacturers More warning letters issued

9:32 AM MDT | June 30, 2014 | —Deepti Ramesh

FDA has, since 2013, issued warning letters to several active pharmaceutical ingredient (API) manufacturing facilities in India. FDA issues such a letter when an agency inspection of a facility identifies significant deviations from cGMP and the company that owns the facility fails to take sufficiently correct the issues. Until all corrections are completed, FDA may withhold approving any new drugs that list that firm as an API manufacturer or refuse to admit APIs manufactured at that facility into the United States. These separate warning letters include those...

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