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, 2011 Medical Science Monitor

But it was scary

For example, the warning letter to Curexa includes a section on corrective actions, noting that FDA cannot fully evaluate the adequacy of the following corrective actions described in your [Form-483] response because you did not include sufficient information or supporting documentation. 12 The agency then goes on to list specific observations from the Form-483 with a detailed description of why Curexas responses were not sufficient