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•Korea (the Republic of)

CG MedTech Co. Ltd, Seongnam, Korea (the Republic of) – FDA Inspections

Inspection records and compliance data for CG MedTech Co. Ltd in Seongnam. 4 FDA inspections on record, last inspected September 08, 2026.

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Company Profile

This profile covers CG MedTech Co. Ltd based in Seongnam, Korea (the Republic of).

FDA Inspection History

FDA inspections
4
OAI
0
VAI
3
NAI
0
Unclassified
1
Form 483s
0
Warning letters
0

First inspected September 25, 2009. Last inspected September 8, 2026.

Most cited issue areas

  • Contamination control, Lack of or inadequate procedures1 inspection
  • DHR - not or inadequately maintained1 inspection
  • Timely informing of consignees1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
September 8, 2026Not classifiedBiologics1341056
September 11, 2025VAIMedical Devices & Rad Health · Compliance: Devices1281106
March 25, 2016VAIBiologics · Human Cellular, Tissue, and Gene Therapies966649
September 25, 2009VAIBiologics · Human Cellular, Tissue, and Gene Therapies620307
FDA documents

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

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Company Information

Name

CG MedTech Co. Ltd

FEI Number

3006724198

Address

Jungwon, Gyeonggi, Jungwon; 244 Galmachi-Ro; Jungwon, Seongnam, Korea (the Republic of)

Country

Korea (the Republic of)

ID: ad3399fe-fe3f-4a17-a987-f3c21755997c

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