FDA Inspection 871149 — Max Mobility LLC
The FDA completed an inspection of Max Mobility LLC on March 27, 2014 in Lebanon, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 27, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lebanon, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |