FDA Inspection
Oceanic Medical Products, Inc.Oceanic Medical Products, Inc. – FDA Inspection, Aug 10, 2018
Record Details
This FDA Inspection record concerns Oceanic Medical Products, Inc., with an inspection on August 10, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f627af04-fe2a-4c66-9af0-d06b174f9bb6
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1061706
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Oceanic Medical Products, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 15, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 4, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Oceanic Medical Products, Inc.
- FDA Inspection 885267 - 2014-06-18
- FDA Inspection 695100 - 2010-10-15
- FDA Inspection 601980 - 2009-08-04
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