FDA Inspection 1014280 — NeuroLogica Corporation
The FDA completed an inspection of NeuroLogica Corporation on June 15, 2017 in Danvers, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 15, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Danvers, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5008 | 21 CFR 1002.20(a) | Failure to report |
| 5802 | 21 CFR 1002.13 | Lack of required elements |