Company
United StatesSamsung Electronics America, Inc., Ridgefield Park, NJ – FDA Inspections
Inspection records and compliance data for Samsung Electronics America, Inc. in Ridgefield Park, New Jersey. 2 FDA inspections on record, last inspected August 19, 2011.
Company Profile
This profile covers Samsung Electronics America, Inc. based in Ridgefield Park, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 16, 2008. Last inspected August 19, 2011.
Most cited issue areas
- Lack of or inadequate DHR procedures1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
- Lack of or inadequate receiving acceptance procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 19, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 742094 |
| December 16, 2008 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 553658 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Samsung Electronics America, Inc.
FEI Number
3003492170
Address
85 Challenger Rd, Ridgefield Park, New Jersey 07660, United States
Country
United States
ID: 15fb2965-e385-43b6-aa9b-6708eb4b596c