FDA Inspection
American IV Products, Inc.American IV Products, Inc. – FDA Inspection, Sep 12, 2018
Record Details
This FDA Inspection record concerns American IV Products, Inc., with an inspection on September 12, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · dc15810b-044b-4c64-a3a3-c60db2fcdc99
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066151
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of American IV Products, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 19, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 9, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 27, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 21, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for American IV Products, Inc.
- FDA Inspection 1246121 - 2024-08-12
- FDA Inspection 987959 - 2016-10-19
- FDA Inspection 874152 - 2014-04-09
- FDA Inspection 734086 - 2011-07-27
- FDA Inspection 672266 - 2010-07-21
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.