FDA Inspection 1199364 — Trophy SAS
The FDA completed an inspection of Trophy SAS on March 10, 2023 in Marne La Vallee Cedex 2. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Marne La Vallee Cedex 2 (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 5012 | 21 CFR 1003.10(a) | FDA not notified of defect or noncompliance |