Company
Korea (the Republic of)Tae-Chang Industrial Co., Ltd., Gumi, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Tae-Chang Industrial Co., Ltd. in Gumi. 2 FDA inspections on record, 1 Form 483, last inspected February 13, 2025.
Company Profile
This profile covers Tae-Chang Industrial Co., Ltd. based in Gumi, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 14, 2019. Last inspected February 13, 2025.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 13, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1261808 |
| March 14, 2019 | Not classified | Medical Devices & Rad Health | 1087873 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Tae-Chang Industrial Co., Ltd.
FEI Number
3011676762
Address
127 Sanhodae-Ro, Gumi, Korea (the Republic of)
Country
Korea (the Republic of)
ID: ce2fddc5-24f6-4114-aa4a-b83b62992e51