FDA Inspection 1061362 — OCCK Inc
The FDA completed an inspection of OCCK Inc on Aug 7, 2018 in Concordia, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 7, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Concordia, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |