# FDA 483 - Radiometer Basel AG - October 20, 2016

Source: https://www.globalkeysolutions.net/records/483/radiometer-basel-ag/37407e05-4f56-4273-9ea7-1a6371f2254a

> FDA 483 for Radiometer Basel AG on October 20, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Radiometer Basel AG
- Inspection Date: 2016-10-20
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Radiometer Basel AG, a medical device manufacturer in Basel, Switzerland, was cited for two significant observations during an FDA inspection. The firm failed to adequately verify design output against design input requirements for its TCM5 monitor and lacked established procedures for controlling nonconforming products. These issues highlight deficiencies in the company's quality system.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/radiometer-basel-ag/4c0d1b05-e674-4961-bf6b-9f97ee873689

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