FDA Inspection 1229603 — NeuroLogica Corporation
The FDA completed an inspection of NeuroLogica Corporation on August 27, 2024 in Danvers, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 27, 2024
- Fiscal Year
- 2024
- 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 |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |