FDA inspection

Astute Medical, Inc.: FDA inspection ending Feb 11, 2016

FDA inspection 965157 · Voluntary Action Indicated (VAI) · San Diego, CA

Key facts

Inspection ID 965157
Firm Astute Medical, Inc.
FEI number 3009834061
Address 3550 General Atomics Ct
City San Diego
State CA
ZIP 92121
Country United States
Fiscal year 2016
Inspection end date Feb 11, 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
  • 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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