Date: 28 Jan 11
Link: FDA Warning Letter (New Window)
ObservationIn addition, we remain concerned that your (b)(4) adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts. The current application was released into production on November 9, 2009 using an Interim Validation report (IVR) that is
Friday, 4 March 2011
CSV FDA Warning Letters : Electronic Records
Posted on 13:07 by Unknown
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