FDA Inspection
North Coast Medical IncNorth Coast Medical Inc – FDA Inspection, Aug 2, 2024
Record Details
This FDA Inspection record concerns North Coast Medical Inc, with an inspection on August 2, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 14580fe0-e71a-445a-9c45-b315980e836b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1245520
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.25(b)Training records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of North Coast Medical Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 30, 2016 | Not classified | San Francisco District Office | Postmarket Assurance: Devices |
| April 24, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 24, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 25, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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