“In the October 10, 2014 written response to the Form FDA 483, you acknowledged this observation. You stated that prior to January 2013, there was no electronic system to track reporting timelines. You indicated that an electronic tracking system was implemented in January 2013 to track monitoring visits and monitoring report reviews. You noted that CRAs receive automatic e-mail reminders and reconciliation is done once per month by the CPM and AB Science management team.
Your written response is inadequate because there are still multiple instances of delayed written reports by the CRAs and delayed approval by the CPM after January 2013.
You proposed a corrective action plan for implementation in the fourth quarter of 2014 where local labs will be captured and queried immediately at the site in the eCRF, and you will continue to use the central lab in phase III trials in addition to local labs for managing safety information.
Your written response is inadequate because your proposed corrective actions make no provisions for assessing the effectiveness of and ensuring sustained compliance with your monitoring practices.”
View the original warning letter.