FDA inspection

Penumbra Inc.: FDA inspection ending Feb 23, 2016

FDA inspection 965001 · Voluntary Action Indicated (VAI) · Alameda, CA

Key facts

Inspection ID 965001
Firm Penumbra Inc.
FEI number 3005168196
Address 1 Penumbra
City Alameda
State CA
ZIP 94502
Country United States
Fiscal year 2016
Inspection end date Feb 23, 2016
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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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