FDA Inspection
Sunbeam Products, Inc.Sunbeam Products, Inc. – FDA Inspection, Aug 3, 2012
Record Details
This FDA Inspection record concerns Sunbeam Products, Inc., with an inspection on August 3, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunbeam Products, Inc.
- Inspection Date
- August 3, 2012
- Product Type
- Devices
View Company Profile
ID · b3c46255-728b-4708-8f37-60b42388be92
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 793902
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 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)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(g)Design validation- 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 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
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 |
| October 30, 2009 | VAI | Center for Devices and Radiological Health | Compliance: 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 625873 - 2009-10-30
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