Company
Korea (the Republic of)Model Solution, Bucheon, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Model Solution in Bucheon, Gyeonggi. 1 FDA inspection on record, last inspected August 22, 2024.
Company Profile
This profile covers Model Solution based in Bucheon, Gyeonggi, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected August 22, 2024.
Most cited issue areas
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 22, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1247573 |
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
Model Solution
FEI Number
3009803802
Address
14 Saneopro104beon-Gil, Bucheon, Gyeonggi 14402, Korea (the Republic of)
Country
Korea (the Republic of)
ID: d7ba6525-b1bd-4d80-817f-7ef44d87e6bb