# FDA 483 - Creagh Medical Ltd - May 16, 2022

Source: https://www.globalkeysolutions.net/records/483/creagh-medical-ltd/b3cde5eb-b07e-4405-a1a4-7d21a691e969

> FDA 483 for Creagh Medical Ltd on May 16, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Creagh Medical Ltd
- Inspection Date: 2022-05-16
- Product Type: device
- Office Name: International Compliance Team
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/creagh-medical-ltd/f47836cc-a9c9-4399-ae7e-0b291a41c773

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321