FDA 483 - Valerie K Arnold MD - March 09, 2007

This Establishment Inspection Report details an FDA Clinical Investigator/Data Audit of Valerie K Arnold MD, conducted from February 19 to March 9, 2007, in Memphis, TN. The inspection, initiated at the request of CDER's Division of Scientific Investigations and related to a high-priority NDA pre-approval assignment, focused on Dr. Arnold's responsibilities as Principal Investigator for two studies. The audit involved extensive review of source data, case report forms, informed consents, and correspondence files, in accordance with CP 7848.811 – Clinical Investigators and Good Clinical Practice principles.

During the 2007 inspection, reviewers identified protocol deviations, including assessments conducted outside specified timeframes and missed visits or dosages. However, the report states that all such instances were fully explained and documented, indicating that no significant actionable violations were observed that warranted an FDA-483 for this particular inspection.

The document also references a prior FDA inspection of Dr. Arnold's site from November to December 2004. That previous audit resulted in an FDA-483 with specific observations: failure to transfer source file changes to CRF copies for three subjects, omission of disorder assessment data for one subject in an interview booklet, and an incorrect entry during a CRF correction. Management had pledged a written response to these earlier findings. For the current 2007 inspection, no immediate required actions were stipulated by the FDA at its conclusion due to the satisfactory explanation of observed deviations.