FDA Inspection 561493 — Wells Johnson Company
The FDA completed an inspection of Wells Johnson Company on January 30, 2009 in Tucson, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tucson, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4058 | 21 CFR 820.20 | Management responsibility |