# FDA 483 - Spineway - July 18, 2019

Source: https://www.keypedia.com/records/483/spineway/263d2f7a-8625-4f81-a180-5126bf7e25b7

> FDA 483 for Spineway on July 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spineway
- Inspection Date: 2019-07-18
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Spineway, a medical device manufacturer in Ecully, France, was inspected by the FDA from July 15-18, 2019. The inspection revealed two significant issues: inadequate procedures for corrective and preventive actions (CAPA) and a failure to submit a Medical Device Report (MDR) within the required 30-day timeframe for a serious injury event. These observations indicate deficiencies in the firm's quality system and regulatory reporting compliance.

## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.keypedia.com/companies/spineway/453416f0-1383-4cd8-bb84-f44243ed34cf

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