# FDA 483 - I.T.S. GmbH - May 03, 2019

Source: https://www.globalkeysolutions.net/records/483/its-gmbh/99db51cb-5763-4473-b532-012b725e0505

> FDA 483 for I.T.S. GmbH on May 03, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: I.T.S. GmbH
- Inspection Date: 2019-05-03
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: T.B.S. GmbH, a manufacturer of Class 2 medical devices, was cited for three observations during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) within 30 days for two instances of broken bone fixation plates. Additionally, the company's corrective and preventive action (CAPA) procedures lacked documented verification of effectiveness, and its supplier evaluation procedures were inadequate, failing to include service providers.

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## Related Officers

- [Stephen R. Souza](https://www.globalkeysolutions.net/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.globalkeysolutions.net/companies/its-gmbh/222e9947-d8bf-4009-9811-979b8bd114c6

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