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

Rechon Life Science AB, a sterile drug products manufacturer in Limhamn, Sweden, was cited for significant deficiencies during an FDA inspection. The observations highlight inadequate aseptic processing controls, including issues with personnel flow, environmental monitoring, and cleaning procedures, leading to potential microbial contamination. Additionally, the firm failed to thoroughly investigate out-of-specification and out-of-trend laboratory results, indicating a lack of robust quality control.