FDA 483 - Rechon Life Science AB - March 17, 2023

Rechon Life Science AB, a human drug manufacturer in Limhamn, Sweden, was cited for significant deficiencies in its aseptic processing, quality control, and investigation systems. The inspection revealed issues with environmental monitoring, microbiological contamination prevention, visual inspection processes, and the thorough review of unexplained discrepancies. These findings indicate a lack of robust controls to ensure the sterility and quality of drug products.