FDA inspection

American Catheter Corp: FDA inspection ending Jan 28, 2016

FDA inspection 956482 · Voluntary Action Indicated (VAI) · Jupiter, FL

Key facts

Inspection ID 956482
Firm American Catheter Corp
FEI number 1000151187
Address 7859 SW Ellipse Way
City Jupiter
State FL
ZIP 33469
Country United States
Fiscal year 2016
Inspection end date Jan 28, 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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