FDA Inspection 682939 — Carrot Medical, LLC
The FDA completed an inspection of Carrot Medical, LLC on September 29, 2010 in Bothell, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 29, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bothell, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |