FDA Inspection
IPAX, IncorporatedIPAX, Incorporated – FDA Inspection, Oct 11, 2018
Record Details
This FDA Inspection record concerns IPAX, Incorporated, with an inspection on October 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · cc649a39-55ac-4f2c-b14c-b1c98c9d22d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1068726
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of IPAX, Incorporated
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2026 | NAI | Denver District Office | Postmarket Assurance: Medical Devices |
| March 2, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 9, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for IPAX, Incorporated
- FDA Inspection 1301452 - 2026-02-05
- FDA Inspection 962189 - 2016-03-02
- FDA Inspection 872747 - 2014-04-09
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.