Company
Korea (the Republic of)SM ENG. Co. Ltd., Sasang, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for SM ENG. Co. Ltd. in Sasang, -. 3 FDA inspections on record, 3 Form 483s, last inspected March 26, 2026.
Company Profile
This profile covers SM ENG. Co. Ltd. based in Sasang, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected July 25, 2019. Last inspected March 26, 2026.
Most cited issue areas
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Lack of or inadequate process validation1 inspection
- Procedures for validation of processes not documented1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 26, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1311000 |
| July 21, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1214471 |
| July 25, 2019 | Not classified | Medical Devices & Rad Health | 1100382 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
SM ENG. Co. Ltd.
FEI Number
3008912461
Address
46 Nakdongdaero1302beon-Gil, Sasang, - -, Korea (the Republic of)
Country
Korea (the Republic of)
ID: b4637d96-5d4d-4f06-9604-bfc923c946a0