FDA Inspection
Marina Medical Instruments Inc.Marina Medical Instruments Inc. – FDA Inspection, Apr 3, 2017
Record Details
This FDA Inspection record concerns Marina Medical Instruments Inc., with an inspection on April 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a1b61c06-6fbf-4b4d-8dd2-f7b48af41fca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1008782
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Marina Medical Instruments Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| January 9, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 9, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 9, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 2, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 2, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Marina Medical Instruments Inc.
- FDA Inspection 862780 - 2014-01-09
- FDA Inspection 862654 - 2014-01-09
- FDA Inspection 862402 - 2014-01-09
- FDA Inspection 788539 - 2012-05-02
- FDA Inspection 788537 - 2012-05-02
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