FDA Inspection
Aktina Medical CorpAktina Medical Corp – FDA Inspection, Jul 24, 2017
Record Details
This FDA Inspection record concerns Aktina Medical Corp, with an inspection on July 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4cfefa03-84e4-45e3-a6e4-b1141a55cac7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018921
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Aktina Medical Corp
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 6, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aktina Medical Corp
- FDA Inspection 818494 - 2013-02-12
- FDA Inspection 629447 - 2009-11-06
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