FDA Inspection
National Creative Enterprises, Inc.National Creative Enterprises, Inc. – FDA Inspection, Jan 11, 2011
Record Details
This FDA Inspection record concerns National Creative Enterprises, Inc., with an inspection on January 11, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 11, 2011
- Product Type
- Devices
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ID · d23415bc-7ff9-45ee-befa-a92b205af748
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 705611
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of National Creative Enterprises, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 3, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 12, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 10, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 5, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for National Creative Enterprises, Inc.
- FDA Inspection 1041632 - 2018-01-03
- FDA Inspection 859974 - 2013-12-12
- FDA Inspection 814035 - 2013-01-10
- FDA Inspection 762230 - 2012-01-05
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