FDA Inspection 630366 — Atrium Medical Corporation
The FDA completed an inspection of Atrium Medical Corporation on November 20, 2009 in Merrimack, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 20, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Merrimack, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |