FDA 483 - City Technology Ltd. - June 08, 2023

During an inspection conducted from June 5-8, 2023, the FDA identified significant deficiencies in the quality system of City Technology Ltd., a medical device manufacturer in Portsmouth, UK. The observations, documented in a Form FDA-483, highlight a failure to comply with several aspects of the medical device Quality System Regulation (21 CFR Part 820). Key violations include inadequate procedures for complaint handling, where approximately 800 customer returns for MOX oxygen sensors alleging issues like "erratic" readings or "leaking" were not formally investigated, and 300 returns lacked documented reasons. Design change procedures were also found lacking, with a specific engineering change not adequately verified or validated, and insufficient hazard identification for MOX sensors. Furthermore, the company failed to validate the final testing process for MOX oxygen sensors to ensure repeatability and reproducibility. Device history records did not fully align with master records, and critical corrective and preventive action (CAPA) procedures were deficient, including missing investigations and lost records. Issues with document control and procedures for controlling nonconforming material were also noted. City Technology Ltd. is required to implement comprehensive corrective actions to address these systemic quality system deficiencies and ensure compliance with regulatory standards.