FDA Inspection 741513 — Medical Quant USA Inc.
The FDA completed an inspection of Medical Quant USA Inc. on September 2, 2011 in Solon, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 2, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Solon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |