FDA Inspection 545087 — MRP, LLC
The FDA completed an inspection of MRP, LLC on October 24, 2008 in Nashville, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 24, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Nashville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2276 | 21 CFR 820.20(b)(1) | Responsibility, authority and independence |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |