FDA Inspection
SonarMed IncSonarMed Inc – FDA Inspection, Mar 29, 2019
Record Details
This FDA Inspection record concerns SonarMed Inc, with an inspection on March 29, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9e639253-67dc-4ff9-a21d-ccc052b4dac4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084308
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(g)Design validation - user needs and intended uses
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