FDA Inspection
Elkem Silicones USA Corp.Elkem Silicones USA Corp. – FDA Inspection, Apr 5, 2018
Record Details
This FDA Inspection record concerns Elkem Silicones USA Corp., with an inspection on April 5, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a2b561b7-6330-49d9-8e49-ba9ef9b9a4f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046970
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Elkem Silicones USA Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Elkem Silicones USA Corp.
- FDA Inspection 1163618 - 2022-02-15
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