FDA Inspection 816910 — Summit Medical, LLC
The FDA completed an inspection of Summit Medical, LLC on January 28, 2013 in Eagan, MN. 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
- January 28, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Eagan, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |