FDA Inspection
Marina Medical Instruments Inc.Marina Medical Instruments Inc. – FDA Inspection, May 2, 2012
Record Details
This FDA Inspection record concerns Marina Medical Instruments Inc., with an inspection on May 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 2, 2012
- Product Type
- Devices
View Company Profile
ID · 51e7a526-0249-4282-9ee1-e35913762a99
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 788539
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Marina Medical Instruments Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Marina Medical Instruments Inc.
- FDA Inspection 1008782 - 2017-04-03
- FDA Inspection 862780 - 2014-01-09
- FDA Inspection 862654 - 2014-01-09
- FDA Inspection 862402 - 2014-01-09
- FDA Inspection 788537 - 2012-05-02
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