FDA inspection

Janssen Diagnostics, LLC: FDA inspection ending Dec 17, 2008

FDA inspection 554382 · Voluntary Action Indicated (VAI) · Raritan, NJ

Key facts

Inspection ID 554382
Firm Janssen Diagnostics, LLC
FEI number 3004619490
Address 1001 US Highway 202
City Raritan
State NJ
ZIP 08869
Country United States
Fiscal year 2009
Inspection end date Dec 17, 2008
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

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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