FDA Inspection 924454 — Infraredx, Inc.
The FDA completed an inspection of Infraredx, Inc. on April 10, 2015 in Bedford, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 10, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Bedford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |