FDA Inspection 808743 — Thermasolutions, LLC
The FDA completed an inspection of Thermasolutions, LLC on November 20, 2012 in White Bear Lake, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 20, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- White Bear Lake, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |