FDA inspection

St. Jude Medical, Implantable Electronic Systems Division: FDA inspection ending Dec 7, 2000

FDA inspection 54908 · Voluntary Action Indicated (VAI) · Sunnyvale, CA

Key facts

Inspection ID 54908
Firm St. Jude Medical, Implantable Electronic Systems Division
FEI number 2938836
Address 645 Almanor Ave
City Sunnyvale
State CA
ZIP 94085-2927
Fiscal year 2001
Inspection end date Dec 7, 2000
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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