FDA Inspection 1004457 — Ives EEG Solutions, LLC
The FDA completed an inspection of Ives EEG Solutions, LLC on March 23, 2017 in Newburyport, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 23, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Newburyport, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |