FDA inspection

Oxysure Systems, Inc.: FDA inspection ending Sep 28, 2015

FDA inspection 944645 · Official Action Indicated (OAI) · Frisco, TX

Key facts

Inspection ID 944645
Firm Oxysure Systems, Inc.
FEI number 3004167951
Address 10880 John W Elliott Dr Ste 600
City Frisco
State TX
ZIP 75033
Country United States
Fiscal year 2015
Inspection end date Sep 28, 2015
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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