FDA 483 - Rhone-Poulenc Rorer Limited - April 01, 2026

An FDA inspection of Rhone-Poulenc Rorer Limited in Holmes Chapel, UK, from April 1-4, 1997, identified a significant quality control issue. The firm's delivery system was not validated, resulting in batches manufactured in 1996 failing to meet finished product specifications for delivery and dose uniformity. This indicates a serious lapse in manufacturing process control.