FDA 483 - Recipharm Monts - October 18, 2022

An FDA inspection of Recipharm Monts, a sterile drug manufacturer in Monts, France, revealed significant deficiencies in its operations. The firm failed to establish and follow adequate procedures to prevent microbiological contamination, lacked proper validation of aseptic and sterilization processes, and exhibited poor cleaning techniques. Additionally, issues were identified in quality control unit responsibilities, data integrity, environmental monitoring, and the stability testing program.