FDA Inspection 673556 — Ansen Corp
The FDA completed an inspection of Ansen Corp on July 9, 2010 in Ogdensburg, NY. 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
- July 9, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ogdensburg, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4249 | 21 CFR 821.25(c) | Not established, maintained |