Rhone- Poulenc Rorer – FDA 483, Jan 18, 1999

An FDA inspection of Rhone-Poulenc Rorer in Maisons-Alfort, France, revealed several deficiencies in the validation, production, and quality control of enoxaparin sodium pre-filled syringes. Observations included inadequate operator gowning, lack of written media fill requirements, insufficient verification during compounding, and issues with batch record integrity. The firm also had deficiencies in cleaning validation, revalidation protocols, out-of-specification procedures, and the conditional release of incoming materials.