FDA Inspection
Ascent Brands, Inc.Ascent Brands, Inc. – FDA Inspection, Aug 11, 2011
Record Details
This FDA Inspection record concerns Ascent Brands, Inc., with an inspection on August 11, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ascent Brands, Inc.
- Inspection Date
- August 11, 2011
- Product Type
- Devices
View Company Profile
ID · c1fa684e-1097-49bc-a5a2-9b52a4c6ad9f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 739284
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR 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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
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 |
| July 10, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Ascent Brands, Inc.
- FDA Inspection 916393 - 2015-03-03
- FDA Inspection 842526 - 2013-07-31
- FDA Inspection 791008 - 2012-07-10
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.