FDA Inspection 768863 — Permobil Inc
The FDA completed an inspection of Permobil Inc on February 16, 2012 in Lebanon, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 16, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lebanon, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 3159 | 21 CFR 820.184 | DHR content |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |