FDA Inspection
Omega Medical Imaging, Inc.Omega Medical Imaging, Inc. – FDA Inspection, Feb 24, 2017
Record Details
This FDA Inspection record concerns Omega Medical Imaging, Inc., with an inspection on February 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f461ea2f-918d-4856-9d05-fe20f190ff55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1004455
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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 |
| November 28, 2018 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| 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 1072961 - 2018-11-28
- FDA Inspection 894276 - 2014-09-05
- FDA Inspection 745586 - 2011-09-19
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