483
Rhone-Poulenc Rorer LimitedRhone-Poulenc Rorer Limited – FDA 483, Apr 1, 1997
Record Details
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.
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