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

An FDA inspection of Rechon Life Science AB, a sterile drug products manufacturer located in Limhamn, Sweden, was conducted from August 26 to September 6, 2024. The inspection revealed significant observations concerning the firm’s adherence to Good Manufacturing Practices (GMP) for aseptic processing. Key violations included deficiencies in maintaining separate and defined aseptic processing areas. Inspectors noted inadequate personnel flow procedures, potentially introducing microbial contamination, evidenced by repeated recovery of gram-negative organisms and spore formers in critical gowning areas, with investigations being inconclusive. The firm also lacked adequate validation of aseptic processes, including a failure to continuously monitor HEPA air velocity in critical Grade A areas. Aseptic behavior during commercial filling setups was observed to be deficient, with operators touching critical surfaces inappropriately. Furthermore, air flow pattern studies and aseptic process simulations were found insufficient, not accurately reflecting real-world interventions or the frequency of such activities. Other issues included an inadequate system for cleaning and disinfecting aseptic areas, as biological indicators showed microbial growth, indicating a failure to achieve microbial control. Environmental monitoring locations were not comprehensive enough, missing critical transfer points. Additionally, the company failed to thoroughly investigate out-of-specification and out-of-trend assay results, invalidating initial findings without scientifically substantiated root causes or manufacturing assessments. Finally, basic facility maintenance was lacking, with sticky surfaces in controlled environments posing contamination risks. To achieve compliance, Rechon Life Science AB is required to promptly address these observations by implementing comprehensive corrective and preventive actions across its quality systems, aseptic processing controls, and facility maintenance.