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•Korea (the Republic of)

GEO Medical Co., Ltd., Korea (the Republic of) – FDA Inspections

Inspection records and compliance data for GEO Medical Co., Ltd. in -. 2 FDA inspections on record, 1 Form 483, last inspected April 13, 2023.

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Company Profile

This profile covers GEO Medical Co., Ltd. based in Korea (the Republic of).

FDA Inspection History

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

First inspected January 31, 2013. Last inspected April 13, 2023.

Most cited issue areas

  • Lack of or inadequate complaint procedures2 inspections
  • Lack of or inadequate process validation2 inspections
  • Design review - Lack of or inadequate procedures1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
April 13, 2023VAIMedical Devices & Rad Health · Compliance: Devices1202409
January 31, 2013VAIMedical Devices & Rad Health · Postmarket Assurance: Devices817938
FDA documents

Form 483s (1)

  • Form 483s · April 13, 2023
People (1)
Jude C. Dike
Person
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Company Information

Name

GEO Medical Co., Ltd.

FEI Number

3008585940

Address

- -, Korea (the Republic of)

Country

Korea (the Republic of)

ID: 22bd135e-206f-48aa-b91f-784475bb262c

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