Company
United StatesOxysure Systems, Inc., Frisco, TX – FDA Inspections
Inspection records and compliance data for Oxysure Systems, Inc. in Frisco, Texas. 2 FDA inspections on record (2 OAI), 1 warning letter, last inspected September 28, 2015.
Company Profile
This profile covers Oxysure Systems, Inc. based in Frisco, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 2
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
First inspected October 3, 2014. Last inspected September 28, 2015.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation acceptance criteria1 inspection
- Design validation - user needs and intended uses1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 28, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 944645 |
| October 3, 2014 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 899019 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Oxysure Systems, Inc.
FEI Number
3004167951
Address
10880 John W Elliott Dr Ste 600, Frisco, Texas 75033, United States
Country
United States
ID: a8b0f299-d8db-4e76-b55b-e86badc16237