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DRG Instruments GmbH, Marburg, Germany – FDA Inspections

Inspection records and compliance data for DRG Instruments GmbH in Marburg. 4 FDA inspections on record (2 OAI), 2 Form 483s, 2 warning letters, last inspected November 07, 2024.

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Company Profile

This profile covers DRG Instruments GmbH based in Marburg, Germany.

FDA Inspection History

FDA inspections
4
OAI
2
VAI
1
NAI
1
Form 483s
2
Warning letters
2

First inspected October 21, 2010. Last inspected November 7, 2024.

Most cited issue areas

  • Devices subject to device identification GUDID data submission requirements.1 inspection
  • DMR - not or inadequately maintained1 inspection
  • Documentation1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
November 7, 2024OAIMedical Devices & Rad Health · Compliance: Medical Devices1254938
October 28, 2016OAIMedical Devices & Rad Health · Compliance: Devices999374
August 22, 2013NAIMedical Devices & Rad Health · Postmarket Assurance: Devices846339
October 21, 2010VAIMedical Devices & Rad Health · Compliance: Devices699317
FDA documents

Form 483s (1)

  • Form 483s · November 7, 2024

Warning Letters (2)

  • Warning Letters · November 7, 2024
  • Warning Letters · October 28, 2016
People (4)
Alberto Gutierrez
Person
Joshua J. Silvestri
Person
Ina Hairston
Person
Simon W. Huang
Person
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Company Information

Name

DRG Instruments GmbH

FEI Number

3002800697

Address

Frauenbergstr. 18, Marburg, Germany

Country

Germany

ID: 5a8981ef-7bb3-4af6-a73f-01be1234ce51

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