FDA Inspection
US Infusion, Inc.US Infusion, Inc. – FDA Inspection, Mar 6, 2023
Record Details
This FDA Inspection record concerns US Infusion, Inc., with an inspection on March 6, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f8830d86-def1-4d95-9d01-30313ef9fa56
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199006
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of US Infusion, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2025 | Not classified | Florida District Office | |
| September 3, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 17, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for US Infusion, Inc.
- FDA Inspection 1277658 - 2025-07-28
- FDA Inspection 941164 - 2015-09-03
- FDA Inspection 896112 - 2014-09-17
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