FDA Inspection 629496 — Summit Medical, LLC
The FDA completed an inspection of Summit Medical, LLC on Nov 6, 2009 in Eagan, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 6, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Eagan, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3162 | 21 CFR 820.184(b) | Quantity manufactured |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3396 | 21 CFR 820.80(d)(1) | DMR required activities {see also 820.181} |