Company
MalaysiaSamsung Electronics, Port Klang, Malaysia – FDA Inspections
Inspection records and compliance data for Samsung Electronics in Port Klang. 5 FDA inspections on record, 1 Form 483, last inspected May 19, 2023.
Company Profile
This profile covers Samsung Electronics based in Port Klang, Malaysia.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 25, 2009. Last inspected May 19, 2023.
Most cited issue areas
- tests--errors and uncertainties accounted for1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 19, 2023 | Not classified | Medical Devices & Rad Health | 1218731 |
| May 15, 2018 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1055087 |
| April 19, 2016 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 969340 |
| July 20, 2012 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 803077 |
| March 25, 2009 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 584186 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Samsung Electronics
FEI Number
1000151690
Address
Lot 2, Area 21, Industrial Park, Lebuh 2, Port Klang, Malaysia
Country
Malaysia
ID: e04d5294-0517-4a44-8c89-2749a585444c