FDA Inspection
Sunbeam Products, Inc.Sunbeam Products, Inc. – FDA Inspection, Jun 19, 2015
Record Details
This FDA Inspection record concerns Sunbeam Products, Inc., with an inspection on June 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunbeam Products, Inc.
- Inspection Date
- June 19, 2015
- Product Type
- Devices
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ID · 39e75980-907d-436b-9353-0892def7bb8f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 933679
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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 28, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 3, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 839700 - 2013-06-28
- FDA Inspection 793902 - 2012-08-03
- FDA Inspection 625873 - 2009-10-30
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