FDA inspection

Qualgen, LLC: FDA inspection ending Sep 4, 2025

FDA inspection 1281118 · Edmond, OK

Key facts

Inspection ID 1281118
Firm Qualgen, LLC
FEI number 3011286349
Address 14844 Bristol Park Blvd
City Edmond
State OK
ZIP 73013-1891
Fiscal year 2025
Inspection end date Sep 4, 2025
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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