FDA Inspection
Soterix Medical, Inc.Soterix Medical, Inc. – FDA Inspection, Aug 24, 2017
Record Details
This FDA Inspection record concerns Soterix Medical, Inc., with an inspection on August 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4910a143-9d8e-4a31-a794-5ce960e468f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1023290
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.181DMR - not or inadequately maintained
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Other FDA inspections of Soterix Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2018 | Not classified | New York District Office |
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