FDA Inspection 984847 — Cook Inc
The FDA completed an inspection of Cook Inc on Jun 17, 2016 in Canton, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 17, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Canton, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |