# FDA 483 - Teleflex Medical Europe Ltd - May 05, 2017

Source: https://www.keypedia.com/records/483/teleflex-medical-europe-ltd/46bdc9ce-0573-4d65-b5e0-ebf06e34f28c

> FDA 483 for Teleflex Medical Europe Ltd on May 05, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teleflex Medical Europe Ltd
- Inspection Date: 2017-05-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Teleflex Medical Europe Ltd in Athlone, Ireland, was inspected from May 2-5, 2017, revealing inadequacies in their design change procedures. The firm failed to adequately establish procedures for design changes, specifically concerning documentation and cross-referencing between various internal control documents. This indicates a moderate severity issue related to their quality system for medical device development.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.keypedia.com/companies/teleflex-medical-europe-ltd/724886b5-3fff-4b69-a700-caa4b7ef0d5b

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