FDA inspection

Audifon-USA, Inc.: FDA inspection ending Nov 27, 2018

FDA inspection 1072952 · Voluntary Action Indicated (VAI) · Debary, FL

Key facts

Inspection ID 1072952
Firm Audifon-USA, Inc.
FEI number 3005384855
Address 403 Chairman Ct Ste 1
City Debary
State FL
ZIP 32713
Country United States
Fiscal year 2019
Inspection end date Nov 27, 2018
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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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