FDA Inspection 652112 — The Soule Company
The FDA completed an inspection of The Soule Company on Mar 19, 2010 in Lutz, FL. 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). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 19, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lutz, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3156 | 21 CFR 820.181(b) | DMR production process specifications |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3303 | 21 CFR 820.100(a)(4) | Verify, validate change {see also 820.100(a)} |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 4189 | 21 CFR 820.198(a) | General |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |