FDA inspection

Roche Molecular Systems, Inc.: FDA inspection ending Jul 31, 2019

FDA inspection 1100926 · No Action Indicated (NAI) · Branchburg, NJ

Key facts

Inspection ID 1100926
Firm Roche Molecular Systems, Inc.
FEI number 2243471
Address 1080 US Highway 202 S
City Branchburg
State NJ
ZIP 08876
Country United States
Fiscal year 2019
Inspection end date Jul 31, 2019
Classification No Action Indicated (NAI)
Project area Blood and Blood Products
Product type Biologics

At a glance

  • None 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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