FDA 483 - Recipharm Monts - November 12, 2019

Recipharm Monts, a sterile drug manufacturer in Monts, France, was cited for deficiencies related to equipment qualification and record keeping during an FDA inspection. The firm failed to maintain records of equipment inspections and did not adequately perform installation qualifications for its labeling, packaging, and filling lines. These issues indicate a lack of proper control over critical manufacturing equipment.