# FDA 483 - ICU Medical de Mexico, S.A. de C.V. - February 18, 2016

Source: https://www.globalkeysolutions.net/records/483/icu-medical-de-mexico-sa-de-cv/448c744c-4011-4f00-a30b-e5868e1643fd

> FDA 483 for ICU Medical de Mexico, S.A. de C.V. on February 18, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ICU Medical de Mexico, S.A. de C.V.
- Inspection Date: 2016-02-18
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: ICU Medical de Mexico, S.A. de C.V. in Maneadero, Mexico, was inspected by the FDA from February 15-18, 2016. The inspection revealed significant deficiencies in process validation, particularly for solvent bonding, and a failure to adequately implement quality audit procedures. Additionally, the firm failed to properly document acceptance activities, specifically functional testing results for assembled units.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/dennis-r-hock/f13e2db1-b808-466d-a974-e5af2d5dfdb0)
- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.globalkeysolutions.net/companies/icu-medical-de-mexico-sa-de-cv/477c2d60-4853-40f2-b20d-b210493e021d

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