FDA Inspection 913076 — Ferno-Washington Inc
The FDA completed an inspection of Ferno-Washington Inc on Mar 11, 2015 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
- Mar 11, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wilmington, OH (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 |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |