FDA Inspection 1054723 — Mobius Medical Systems, LP
The FDA completed an inspection of Mobius Medical Systems, LP on Jun 7, 2018 in Houston, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 7, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |