FDA Inspection 725276 — Axiobionics, LLC
The FDA completed an inspection of Axiobionics, LLC on Jun 29, 2011 in Ann Arbor, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 29, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3837 | 21 CFR 820.25(b) | Training records |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |