# FDA 483 - In2Bones, SAS - October 27, 2016

Source: https://www.globalkeysolutions.net/records/483/in2bones-sas/a123d587-df8c-425e-b5b8-dc6ff8cad112

> FDA 483 for In2Bones, SAS on October 27, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: In2Bones, SAS
- Inspection Date: 2016-10-27
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of In2Bones, SAS, a device manufacturer in Ecully, France, identified one observation related to quality system deficiencies. The firm's procedures for supplier control were found to be inadequately defined, specifically regarding follow-up actions based on supplier evaluations. This indicates a moderate severity issue concerning quality management system oversight.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/in2bones-sas/a6ace8d6-5478-41db-a279-7e5040ea72d1

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