FDA Inspection 1001452 — Valorem Surgical LLC
The FDA completed an inspection of Valorem Surgical LLC on October 26, 2016 in Chicago, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 26, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3837 | 21 CFR 820.25(b) | Training records |