FDA Inspection 711756 — Cooperative Workshops Inc
The FDA completed an inspection of Cooperative Workshops Inc on March 1, 2011 in Sedalia, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 1, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sedalia, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |