FDA inspection

Audina Hearing Instrument: FDA inspection ending May 16, 2017

FDA inspection 1013192 · Voluntary Action Indicated (VAI) · Longwood, FL

Key facts

Inspection ID 1013192
Firm Audina Hearing Instrument
FEI number 1000113652
Address 165 E Wildmere Ave
City Longwood
State FL
ZIP 32750
Country United States
Fiscal year 2017
Inspection end date May 16, 2017
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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