# FDA 483 - GAELTEC DEVICES LTD - December 07, 2017

Source: https://www.keypedia.com/records/483/gaeltec-devices-ltd/dfdc653e-14e5-408a-ba78-d2985d634200

> FDA 483 for GAELTEC DEVICES LTD on December 07, 2017. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: GAELTEC DEVICES LTD
- Inspection Date: 2017-12-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of GASTEC DEVICES LTD, a medical device manufacturer in Dunvegan, United Kingdom, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures related to process validation, corrective and preventive actions, complaint handling, equipment maintenance, and device history records. These findings indicate a lack of robust controls necessary for ensuring product quality and regulatory 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/gaeltec-devices-ltd/838cf56d-173a-4155-b69c-d26959065835

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd