FDA inspection

Roche Molecular Systems, Inc.: FDA inspection ending Apr 12, 2004

FDA inspection 321566 · Voluntary Action Indicated (VAI) · Pleasanton, CA

Key facts

Inspection ID 321566
Firm Roche Molecular Systems, Inc.
FEI number 3004141078
Address 4300 Hacienda Dr
City Pleasanton
State CA
ZIP 94588-2722
Fiscal year 2004
Inspection end date Apr 12, 2004
Classification Voluntary Action Indicated (VAI)
Project area Product Evaluation: Med Devices
Product type Devices

At a glance

  • None Citations
  • 1–9 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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