FDA Inspection
Silex Medical, LLCSilex Medical, LLC – FDA Inspection, Nov 18, 2015
Record Details
This FDA Inspection record concerns Silex Medical, LLC, with an inspection on November 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Silex Medical, LLC
- Inspection Date
- November 18, 2015
- Product Type
- Devices
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ID · ced743eb-c57d-4d67-897d-91896a860829
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 951672
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Silex Medical, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2025 | NAI | New England District Office | Postmarket Assurance: Medical Devices |
| June 11, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 22, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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