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

An FDA inspection of Rechon Life Science AB in Limhamn, Sweden, revealed significant deficiencies in aseptic processing, environmental monitoring, and contamination control. The firm failed to establish scientifically justified contamination recovery limits, ensure proper operator qualification for aseptic interventions, and adequately investigate recurring discrepancies like abnormal flora and leak test failures. These issues indicate a lack of robust quality systems necessary for sterile drug product manufacturing.