FDA Inspection 1098770 — Kobold, LLC
The FDA completed an inspection of Kobold, LLC on August 2, 2019 in Liberty Lake, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 2, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Liberty Lake, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |