FDA Inspection 731317 — Natus Medical Inc
The FDA completed an inspection of Natus Medical Inc on Jun 30, 2011 in Mundelein, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 30, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mundelein, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |