FDA Inspection
Sunbeam Products, Inc.Sunbeam Products, Inc. – FDA Inspection, Oct 30, 2009
Record Details
This FDA Inspection record concerns Sunbeam Products, Inc., with an inspection on October 30, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunbeam Products, Inc.
- Inspection Date
- October 30, 2009
- Product Type
- Devices
View Company Profile
ID · 80662f75-1d5f-46af-b477-f7a18ec35995
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 625873
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(e)(6)Results of investigation
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Other FDA inspections of Sunbeam Products, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 19, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 28, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 3, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sunbeam Products, Inc.
- FDA Inspection 1067545 - 2018-08-23
- FDA Inspection 933679 - 2015-06-19
- FDA Inspection 839700 - 2013-06-28
- FDA Inspection 793902 - 2012-08-03
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