FDA Inspection 705611 — National Creative Enterprises, Inc.
The FDA completed an inspection of National Creative Enterprises, Inc. on January 11, 2011 in Burnsville, MN. 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
- January 11, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Burnsville, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |