Company
Korea (the Republic of)SMC, Gimpo, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for SMC in Gimpo, -. 2 FDA inspections on record, 2 Form 483s, last inspected December 11, 2025.
Company Profile
This profile covers SMC based in Gimpo, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected May 30, 2019. Last inspected December 11, 2025.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack of or inadequate DHR procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 11, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1296686 |
| May 30, 2019 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1091659 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
SMC
FEI Number
3011221234
Address
30 Daeposandan-Ro, Yangchon-Eup, Gimpo, - -, Korea (the Republic of)
Country
Korea (the Republic of)
ID: b3d1d209-b929-4dbc-bbd5-d4eaabcaf24d