FDA 483 - Creagh Medical Ltd - May 16, 2022

Creagh Medical Ltd. in Ballinasloe, County Galway, Ireland, was inspected by the FDA from May 16-19, 2022. The inspection revealed three significant issues, including inadequate procedures for handling customer complaints, failure to submit a supplemental Medical Device Report (MDR) for a remedial action, and deficiencies in environmental control procedures, specifically regarding compressed air filtration and hand sanitization frequency. These findings indicate a need for improved quality system controls.