# FDA 483 - Centro de Construccion de Cardioestimuladores del Uruguay SA - August 18, 2022

Source: https://www.globalkeysolutions.net/records/483/centro-de-construccion-de-cardioestimuladores-del-uruguay-sa/8aef0e2e-4b5a-44c6-82b6-460ba07fbbb4

> FDA 483 for Centro de Construccion de Cardioestimuladores del Uruguay SA on August 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Centro de Construccion de Cardioestimuladores del Uruguay SA
- Inspection Date: 2022-08-18
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Centro de Construccion de Cardioestimuladores del Uruguay SA, a contract manufacturer and sterilizer in Montevideo, Uruguay, revealed a significant quality system deficiency. The firm was cited for using test equipment with out-of-date calibration labels for troubleshooting a Class III medical device, indicating a failure to ensure equipment suitability for its intended purpose.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)

Company: https://www.globalkeysolutions.net/companies/centro-de-construccion-de-cardioestimuladores-del-uruguay-sa/632d806f-0de2-4c03-89fe-5674a30b9a98

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