FDA Inspection
Omega Medical Imaging, Inc.Omega Medical Imaging, Inc. – FDA Inspection, Nov 28, 2018
Record Details
This FDA Inspection record concerns Omega Medical Imaging, Inc., with an inspection on November 28, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · e2ab820f-ce63-4a4c-8678-19bf1a4187d6
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1072961
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Omega Medical Imaging, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 26, 2022 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| February 24, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 5, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 19, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Omega Medical Imaging, Inc.
- FDA Inspection 1287420 - 2025-09-29
- FDA Inspection 1178285 - 2022-08-26
- FDA Inspection 1004455 - 2017-02-24
- FDA Inspection 894276 - 2014-09-05
- FDA Inspection 745586 - 2011-09-19
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.