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•United States

Omega Medical Imaging, Inc., Sanford, FL – FDA Inspections

Inspection records and compliance data for Omega Medical Imaging, Inc. in Sanford, Florida. 7 FDA inspections on record, 2 Form 483s, last inspected September 29, 2025.

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Company Profile

This profile covers Omega Medical Imaging, Inc. based in Sanford, Florida, United States.

FDA Inspection History

FDA inspections
7
OAI
0
VAI
3
NAI
4
Form 483s
2
Warning letters
0

First inspected January 9, 2009. Last inspected September 29, 2025.

Most cited issue areas

  • Lack of or inadequate procedures2 inspections
  • Environmental control Lack of or inadequate procedures1 inspection
  • Justification for not reporting1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
September 29, 2025NAIMedical Devices & Rad Health · Compliance: Devices1287420
August 26, 2022NAIMedical Devices & Rad Health · Radiation Control and Health Safety Act1178285
November 28, 2018NAIMedical Devices & Rad Health · Radiation Control and Health Safety Act1072961
February 24, 2017VAIMedical Devices & Rad Health · Compliance: Devices1004455
September 5, 2014VAIMedical Devices & Rad Health · Compliance: Devices894276
September 19, 2011NAIMedical Devices & Rad Health · Postmarket Assurance: Devices745586
January 9, 2009VAIMedical Devices & Rad Health · Compliance: Devices556128
FDA documents

Form 483s (1)

  • Form 483s · August 26, 2022
People (2)
Brandon P. Thompson
Person
Eric C. Fox
Person
Related Companies (10)

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Ventana Medical Systems, Inc.
Physio-Control, Inc.
Boston Scientific Corporation
AngioDynamics, Inc.
Abbott Vascular Inc
Edwards Lifesciences, LLC
Abbott
Medtronic Inc.
Stryker Corporation
Microgenics Corporation
Company Information

Name

Omega Medical Imaging, Inc.

FEI Number

1000222289

Address

3400 Saint Johns Pkwy Ste 1020, Sanford, Florida 32771, United States

Country

United States

ID: 74d04b67-394a-442a-b4f2-08d3f58760c3

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