FDA Inspection 1084818 — SURGIX MEDICAL LLC
The FDA completed an inspection of SURGIX MEDICAL LLC on April 2, 2019 in Spring, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 2, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: 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 |