FDA 483 - Rechon Life Science AB - September 06, 2024

The FDA inspection of Rechon Life Science AB in Limhamn, Sweden, a sterile drug products manufacturer, identified critical deficiencies across its aseptic processing, environmental control, and quality control operations. Key issues include inadequate personnel flow and gowning procedures, insufficient validation of aseptic processes, and ineffective cleaning and disinfection protocols. Additionally, the firm failed to thoroughly investigate out-of-specification results and maintain its facilities in a good state of repair, indicating a significant lack of control over processes vital for product sterility and quality.