FDA Inspection
Oxysure Systems, Inc.Oxysure Systems, Inc. – FDA Inspection, Sep 28, 2015
Record Details
This FDA Inspection record concerns Oxysure Systems, Inc., with an inspection on September 28, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Oxysure Systems, Inc.
- Inspection Date
- September 28, 2015
- Product Type
- Devices
View Company Profile
ID · d8863e0a-d3a0-4a55-8b08-314368d37713
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 944645
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Oxysure Systems, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 3, 2014 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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