FDA Inspection 1084818 — SURGIX MEDICAL LLC
The FDA completed an inspection of SURGIX MEDICAL LLC on Apr 2, 2019 in Spring, 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
- Apr 2, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Spring, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |