FDA inspection

Medtronic Puerto Rico Operations Co.: FDA inspection ending May 14, 2010

FDA inspection 663875 · Voluntary Action Indicated (VAI) · Villalba, PR

Key facts

Inspection ID 663875
Firm Medtronic Puerto Rico Operations Co.
FEI number 2649622
Address Road 149 Km 56.3
City Villalba
State PR
ZIP 00766
Country United States
Fiscal year 2010
Inspection end date May 14, 2010
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
  • 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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