FDA Inspection 542580 — Natus Medical Incorporated
The FDA completed an inspection of Natus Medical Incorporated on October 8, 2008 in Seattle, WA. 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
- October 8, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |