FDA Inspection
Viscot Medical LLCViscot Medical LLC – FDA Inspection, Dec 19, 2013
Record Details
This FDA Inspection record concerns Viscot Medical LLC, with an inspection on December 19, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Viscot Medical LLC
- Inspection Date
- December 19, 2013
- Product Type
- Devices
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ID · 405ca852-40d4-47ed-aedb-d8b77627ab7b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 861699
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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Other FDA inspections of Viscot Medical LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 20, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 27, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 16, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Viscot Medical LLC
- FDA Inspection 1264137 - 2025-03-03
- FDA Inspection 1171580 - 2022-04-20
- FDA Inspection 1044420 - 2018-02-27
- FDA Inspection 724636 - 2011-05-16
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