FDA Inspection 1253833 — Ensitevascular LLC
The FDA completed an inspection of Ensitevascular LLC on Nov 6, 2024 in Overland Park, KS. 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
- Nov 6, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Overland Park, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |