FDA 483 - Recipharm Monts - February 26, 2013

Recipharm Monts, a drug product manufacturer in Monts, France, was cited for significant deficiencies in equipment design, maintenance, and procedural adherence during an FDA inspection. Observations included malfunctioning visual inspection systems leading to miscounts, inadequate complaint handling procedures, and a deficient stability testing program. These issues indicate a lack of control over critical manufacturing and quality processes.