Company
United StatesIPAX, Incorporated, Englewood, CO – FDA Inspections
Inspection records and compliance data for IPAX, Incorporated in Englewood, Colorado. 4 FDA inspections on record, 2 Form 483s, last inspected February 05, 2026.
Company Profile
This profile covers IPAX, Incorporated based in Englewood, Colorado, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 9, 2014. Last inspected February 5, 2026.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Product realization risk management processes not documented1 inspection
- Product rework procedures, Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 5, 2026 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1301452 |
| October 11, 2018 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1068726 |
| March 2, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 962189 |
| April 9, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 872747 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
IPAX, Incorporated
FEI Number
1720734
Address
2700 S Raritan St, Englewood, Colorado 80110, United States
Country
United States
ID: 348a717b-4dba-4cb6-8781-82a8917ab9fe