FDA inspection

Cardiovascular Systems, Inc.: FDA inspection ending Dec 12, 2014

FDA inspection 908364 · Voluntary Action Indicated (VAI) · Pearland, TX

Key facts

Inspection ID 908364
Firm Cardiovascular Systems, Inc.
FEI number 3008814558
Address 14740 Kirby Dr
City Pearland
State TX
ZIP 77047
Country United States
Fiscal year 2015
Inspection end date Dec 12, 2014
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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