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Aesku Group GmbH & Co. KG, Wendelsheim, Germany – FDA Inspections

Inspection records and compliance data for Aesku Group GmbH & Co. KG in Wendelsheim. 2 FDA inspections on record, 2 Form 483s, last inspected March 29, 2019.

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Company Profile

This profile covers Aesku Group GmbH & Co. KG based in Wendelsheim, Germany.

FDA Inspection History

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

First inspected March 2, 2017. Last inspected March 29, 2019.

Most cited issue areas

  • Lack of or inadequate procedures1 inspection
  • Nonconforming product, Lack of or inadequate procedures1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
March 29, 2019Not classifiedMedical Devices & Rad Health1156862
March 2, 2017VAIMedical Devices & Rad Health · Compliance: Devices1008028
FDA documents

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

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Company Information

Name

Aesku Group GmbH & Co. KG

FEI Number

3003825930

Address

Mikro-Forum-Ring 2, Wendelsheim, Germany

Country

Germany

ID: b47ca8d5-16b1-4e6f-94ca-b26458167f5d

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