FDA Inspection 1115220 — NeuroLogica Corporation
The FDA completed an inspection of NeuroLogica Corporation on January 14, 2020 in Danvers, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 14, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Danvers, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 5812 | 21 CFR 1002.30(a)(2) | Results of tests |