FDA 483 - Rhone-Poulenc Rorer - April 27, 2026

An FDA inspection of Rhone-Poulenc Rorer in Dagenham, Essex U.K. from April 27-30, 1998, identified deficiencies related to manufacturing practices for FERRLECIT INJECTION. Observations included unfinalized Standard Operating Procedures and validation activities, along with inadequate monitoring practices.