FDA Inspection 744780 — Ferno-Washington Inc
The FDA completed an inspection of Ferno-Washington Inc on Sep 29, 2011 in Wilmington, OH. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 29, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wilmington, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |