FDA Inspection
Samsung Electronics America, Inc.Samsung Electronics America, Inc. – FDA Inspection, Aug 19, 2011
Record Details
This FDA Inspection record concerns Samsung Electronics America, Inc., with an inspection on August 19, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 19, 2011
- Product Type
- Devices
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ID · 88a989c0-9b84-4018-8789-d49e8f973822
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 742094
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
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Other FDA inspections of Samsung Electronics America, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 16, 2008 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Samsung Electronics America, Inc.
- FDA Inspection 553658 - 2008-12-16
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