FDA Inspection 1276323 — Woven Orthopedic Technologies, LLC
The FDA completed an inspection of Woven Orthopedic Technologies, LLC on Jul 23, 2025 in Stamford, CT. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 23, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Stamford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |