FDA Inspection
Alcor Scientific, Inc.Alcor Scientific, Inc. – FDA Inspection, Dec 18, 2018
Record Details
This FDA Inspection record concerns Alcor Scientific, Inc., with an inspection on December 18, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9a047829-9291-4065-bd0f-dee29a2f2ac0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074839
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Alcor Scientific, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 30, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 31, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Alcor Scientific, Inc.
- FDA Inspection 782014 - 2012-05-09
- FDA Inspection 718263 - 2011-03-30
- FDA Inspection 638618 - 2009-12-31
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