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Hebumedical GMBH, Tuttlingen, Germany – FDA Inspections

Inspection records and compliance data for Hebumedical GMBH in Tuttlingen. 2 FDA inspections on record, last inspected November 02, 2018.

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Company Profile

This profile covers Hebumedical GMBH based in Tuttlingen, Germany.

FDA Inspection History

FDA inspections
2
OAI
0
VAI
1
NAI
1
Form 483s
0
Warning letters
0

First inspected June 2, 2016. Last inspected November 2, 2018.

Most cited issue areas

  • Design history file1 inspection
  • DMR - not or inadequately maintained1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
November 2, 2018NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1074029
June 2, 2016VAIMedical Devices & Rad Health · Compliance: Devices975461
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Company Information

Name

Hebumedical GMBH

FEI Number

3008782585

Address

Badstr. 8, Tuttlingen, Germany

Country

Germany

ID: 68e996a1-633b-4f62-a24d-728626d32218

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