FDA inspection

Janssen Ortho LLC: FDA inspection ending Jun 5, 2026

FDA inspection 1320870 · Gurabo, PR

Key facts

Inspection ID 1320870
Firm Janssen Ortho LLC
FEI number 3002942061
Address State Road 933 Km 0.1,Mamey Ward
City Gurabo
State PR
ZIP 00778-8831
Fiscal year 2026
Inspection end date Jun 5, 2026
Product type Drugs

At a glance

  • 1–9 Citations
  • None Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 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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