FDA Inspection
OMNIA, Inc.OMNIA, Inc. – FDA Inspection, Mar 28, 2017
Record Details
This FDA Inspection record concerns OMNIA, Inc., with an inspection on March 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f75e2d77-65cf-4d74-930e-6c996208568b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007422
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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