FDA Inspection 1101173 — IR Techology LLC
The FDA completed an inspection of IR Techology LLC on Sep 5, 2019 in Woodstock, GA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 5, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Woodstock, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |