FDA 483 - Recipharm Monts - June 09, 2015

An FDA inspection of Recipharm Monts in Monts, France, revealed significant deficiencies in manufacturing practices. Observations included failures in preventing contamination during component handling and drug product filling, inadequate environmental controls for microorganisms, and insufficient laboratory testing for objectionable microorganisms in drug products. These issues indicate a lack of robust quality control in critical production areas.