FDA inspection

Denterprise International, Inc.: FDA inspection ending Mar 12, 2018

FDA inspection 1044362 · Official Action Indicated (OAI) · Ormond Beach, FL

Key facts

Inspection ID 1044362
Firm Denterprise International, Inc.
FEI number 1000113729
Address 156 E Granada Blvd
City Ormond Beach
State FL
ZIP 32176
Country United States
Fiscal year 2018
Inspection end date Mar 12, 2018
Classification Official Action Indicated (OAI)
Project area Radiation Control and Health Safety Act
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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