FDA Inspection 760495 — InterX Technologies
The FDA completed an inspection of InterX Technologies on Jan 5, 2012 in Plano, TX. 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
- Jan 5, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Plano, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |