FDA Inspection 1236226 — Image Diagnostics, Inc.
The FDA completed an inspection of Image Diagnostics, Inc. on Apr 18, 2024 in Fitchburg, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Apr 18, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fitchburg, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |