FDA EIR - Spartanburg Medical Research - November 09, 2017

An FDA inspection of Spartanburg Medical Research was conducted from November 6 to November 9, 2017. This bioequivalence inspection, aligned with Compliance Program CP7348.001 for Clinical Investigators, aimed to assess the site's adherence to regulatory standards for drug studies, specifically for a CDER GDUFA Bioequivalence assignment. During the audit, the facility demonstrated compliance across various aspects of clinical trial conduct, including protocol adherence, informed consent procedures, subject record management, drug accountability, and IRB review processes. The only concern identified related to the contents of a sample blinding envelope, which initially failed to clearly identify the test and reference drugs. However, this issue was promptly addressed and rectified during the inspection, with correct information obtained and documented. It was noted that the site was not responsible for creating this specific blinding information. Crucially, no significant deviations were found, and no FDA-483 (Inspectional Observations) was issued at the close of the inspection. Consequently, the inspection was classified as NAI (No Action Indicated), indicating satisfactory compliance with regulatory requirements and no need for corrective actions from the company. The previous inspection in 2004 also resulted in a NAI classification.