Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1720734.
Observations1
Issue DateFebruary 05, 2026
StatusNo Warning Letter
Establishment TypeContract Manufacturer
Related Inspections4
Establishment Details
Firm
IPAX, Incorporated
Location
Englewood, Colorado
FEI Number
1720734
Establishment Type
Contract Manufacturer
Product Type
Devices
Issue Date
February 05, 2026
Country
United States
Inspection History, 2014 to 2026
NAI1
VAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
Talk to a Specialist