# FDA 483 - Caragh Precision - July 17, 2025

Source: https://www.keypedia.com/records/483/caragh-precision/c1393389-5138-46e6-ba1d-a5aaeb0f78e0

> FDA 483 for Caragh Precision on July 17, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Caragh Precision
- Inspection Date: 2025-07-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Caragh Precision, a medical device manufacturer in Galway, Ireland, received a Form FDA-483 with three observations during an inspection. The inspection revealed deficiencies in the firm's supplier assessment, change control, and corrective and preventive action procedures. These issues indicate a need for improved quality system controls to ensure product quality and compliance.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.keypedia.com/companies/caragh-precision/694cefc0-eca0-4d38-9f6e-7b8f9554cc55

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4