FDA Inspection 1062952 — NATUS MEDICAL INCORPORATED
The FDA completed an inspection of NATUS MEDICAL INCORPORATED on Aug 14, 2018 in Oakville. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 14, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oakville (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |