FDA inspection

Cardiovascular Systems, Inc.: FDA inspection ending Jul 12, 2016

FDA inspection 978650 · No Action Indicated (NAI) · Pearland, TX

Key facts

Inspection ID 978650
Firm Cardiovascular Systems, Inc.
FEI number 3008814558
Address 14740 Kirby Dr
City Pearland
State TX
ZIP 77047
Country United States
Fiscal year 2016
Inspection end date Jul 12, 2016
Classification No Action Indicated (NAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes 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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