FDA Inspection
US Infusion, Inc.US Infusion, Inc. – FDA Inspection, Sep 17, 2014
Record Details
This FDA Inspection record concerns US Infusion, Inc., with an inspection on September 17, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- US Infusion, Inc.
- Inspection Date
- September 17, 2014
- Product Type
- Devices
View Company Profile
ID · 4f29bbc8-5cad-494f-9ca5-ec61df5f5566
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 896112
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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 | |
| March 6, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 3, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for US Infusion, Inc.
- FDA Inspection 1277658 - 2025-07-28
- FDA Inspection 1199006 - 2023-03-06
- FDA Inspection 941164 - 2015-09-03
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