FDA Inspection
National Creative Enterprises, Inc.National Creative Enterprises, Inc. – FDA Inspection, Jan 5, 2012
Record Details
This FDA Inspection record concerns National Creative Enterprises, Inc., with an inspection on January 5, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 5, 2012
- Product Type
- Devices
View Company Profile
ID · 7f90b228-98f2-4379-9c29-1fa3e38759ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 762230
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 11, 2011 | OAI | 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 705611 - 2011-01-11
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