FDA inspection

Cogentix Medical, Inc.: FDA inspection ending Aug 8, 2014

FDA inspection 890802 · Voluntary Action Indicated (VAI) · Orangeburg, NY

Key facts

Inspection ID 890802
Firm Cogentix Medical, Inc.
FEI number 2242464
Address 40 Ramland Rd S
City Orangeburg
State NY
ZIP 10962
Country United States
Fiscal year 2014
Inspection end date Aug 8, 2014
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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