FDA Inspection 1117146 — Cook Incorporated
The FDA completed an inspection of Cook Incorporated on February 7, 2020 in Bloomington, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 7, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bloomington, IN (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 |
| 3312 | 21 CFR 820.120(d) | Mixups |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |