FDA Inspection
Sunbeam Products Inc.Sunbeam Products Inc. – FDA Inspection, Feb 28, 2014
Record Details
This FDA Inspection record concerns Sunbeam Products Inc., with an inspection on February 28, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunbeam Products Inc.
- Inspection Date
- February 28, 2014
- Product Type
- Devices
View Company Profile
ID · d8fcdf59-1364-4b14-8be9-9bc188bb401c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 869263
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sunbeam Products Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 3, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sunbeam Products Inc.
- FDA Inspection 984399 - 2016-07-08
- FDA Inspection 830448 - 2013-05-03
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.