Company
United StatesElkem Silicones USA Corp., East Brunswick, NJ – FDA Inspections
Inspection records and compliance data for Elkem Silicones USA Corp. in East Brunswick, New Jersey. 2 FDA inspections on record, 1 Form 483, last inspected February 15, 2022.
Company Profile
This profile covers Elkem Silicones USA Corp. based in East Brunswick, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 5, 2018. Last inspected February 15, 2022.
Most cited issue areas
- Lack of Written MDR Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 15, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1163618 |
| April 5, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1046970 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Elkem Silicones USA Corp.
FEI Number
3011047015
Address
2 Tower Center Blvd Ste 1802, East Brunswick, New Jersey 08816, United States
Country
United States
ID: 42bd7655-38f9-475f-8b77-e0e0f27b9fe8