Rhone-Poulenc Rorer – FDA 483, Apr 27, 1998

An FDA inspection of Rhone-Poulenc Rorer in Dagenham, Essex U.K. revealed significant deficiencies in quality system controls related to the manufacturing of FERRLECIT INJECTION. Observations included unfinalized standard operating procedures, inadequate monitoring, and incomplete validation activities. These issues indicate a lack of robust control over critical manufacturing processes.