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•Korea (the Republic of)

WINBACK GO EAST CO LTD, Wonju, Korea (the Republic of) – FDA Inspections

Inspection records and compliance data for WINBACK GO EAST CO LTD in Wonju. 1 FDA inspection on record, 1 Form 483, last inspected June 12, 2025.

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Company Profile

This profile covers WINBACK GO EAST CO LTD based in Wonju, Korea (the Republic of).

FDA Inspection History

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

Inspected June 12, 2025.

Most cited issue areas

  • Devices subject to device identification GUDID data submission requirements.1 inspection
  • Lack of or inadequate complaint procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
June 12, 2025NAIMedical Devices & Rad Health · Postmarket Assurance: Medical Devices1272426
FDA documents

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

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Company Information

Name

WINBACK GO EAST CO LTD

FEI Number

3016512343

Address

Usandong, 161 Usangongdan-Gil, Wonju, Korea (the Republic of)

Country

Korea (the Republic of)

ID: f90ae0ce-c54e-423a-a37b-57dcfe27b7ee

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