FDA Inspection
Ascent Brands, Inc.Ascent Brands, Inc. – FDA Inspection, Jul 10, 2012
Record Details
This FDA Inspection record concerns Ascent Brands, Inc., with an inspection on July 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ascent Brands, Inc.
- Inspection Date
- July 10, 2012
- Product Type
- Devices
View Company Profile
ID · 83c84f0d-58ee-459e-af23-51a741827eee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 791008
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.198(b)Rationale documented for no investigation
Showing 10 of 11 citations.
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Other FDA inspections of Ascent Brands, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 31, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 11, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ascent Brands, Inc.
- FDA Inspection 916393 - 2015-03-03
- FDA Inspection 842526 - 2013-07-31
- FDA Inspection 739284 - 2011-08-11
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