FDA Inspection 591763 — G. Dundas Co Inc
The FDA completed an inspection of G. Dundas Co Inc on May 26, 2009 in Black Diamond, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Black Diamond, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |