FDA Inspection
North Coast Medical IncNorth Coast Medical Inc – FDA Inspection, Aug 28, 2023
Record Details
This FDA Inspection record concerns North Coast Medical Inc, with an inspection on August 28, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Jeffrey S. Buckser
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ID · 8f2ee881-b571-43ec-9e4d-e2b31ac185c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1216094
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(b)Review and evaluation for investigation
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Other FDA inspections of North Coast Medical Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2024 | VAI | Center for Devices and Radiological Health | Compliance: 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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