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 3011286349.
Observations5
Issue DateSeptember 04, 2025
StatusNo Warning Letter
Establishment TypeOutsourcing Facility
Related Inspections6
Establishment Details
Firm
Qualgen, LLC
Location
Edmond, Oklahoma, United States
FEI Number
3011286349
Establishment Type
Outsourcing Facility
Product Type
Drugs
Issue Date
September 04, 2025
Country
United States
Inspection History, 2015 to 2024
VAI2
OAI4
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
Talk to a Specialist