Creagh Medical Ltd – FDA 483, 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.
ID · b3cde5eb-b07e-4405-a1a4-7d21a691e969
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