FDA inspection

Dentsply Implants Manufacturing GmbH: FDA inspection ending Jul 25, 2019

FDA inspection 1146083 · Voluntary Action Indicated (VAI) · Hanau

Key facts

Inspection ID 1146083
Firm Dentsply Implants Manufacturing GmbH
FEI number 3013111692
Address Rodenbacher Chaussee 4
City Hanau
Fiscal year 2019
Inspection end date Jul 25, 2019
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Medical 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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