FDA EIR - Allergan Sales, LLC - December 23, 2013

An FDA inspection of Allergan Inc., located in Irvine, CA, was conducted from December 12-23, 2013. This high-priority inspection, under the CDER Sponsor/Monitor/CRO program (CP 7348.810), focused on Allergan's role as a sponsor for two clinical trials (Study #206207-010 and #206207-011) related to NDA #22-315/SE1-009. Although no FDA 483 was issued, the inspection revealed two main areas for improvement. First, Allergan's investigation into a clinical investigator's (Dr. Sall) report of suspected subject data substitution, specifically Optical Coherence Tomography (OCT) scans, was deemed inadequate. The firm relied heavily on a primary vendor for data review without fully exploring the reported issues or considering an independent expert. Second, Allergan lacked complete and verifiable records for test article disposition, preventing 100% reconciliation of investigational products, particularly those handled by foreign depots. Management acknowledged this deficiency, committing to correct the process for comprehensive reconciliation and providing a written response within 15 business days. The FDA suggested Allergan should have considered a third-party expert for the data substitution allegations, to which the firm offered no further response. Overall, the inspection highlighted the need for more robust internal investigations and improved global inventory management for clinical trial materials.