FDA 483 - Rhône-Poulenc Chemie - July 08, 1997

An FDA inspection of RHONE-POULENC CHEMIE in Rousillon, France, revealed several deficiencies related to manufacturing controls and data integrity. Observations included a lack of written sanitation and sampling procedures, an absence of a formalized Master Production Record, and laboratory raw data being recorded on unbound, loose sheets of paper. These issues indicate a need for improved documentation and control over manufacturing processes and data handling.