Company
Korea (the Republic of)Solco Biomedical Co., Ltd., Pyeongtaek, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Solco Biomedical Co., Ltd. in Pyeongtaek. 3 FDA inspections on record, 2 Form 483s, last inspected December 19, 2024.
Company Profile
This profile covers Solco Biomedical Co., Ltd. based in Pyeongtaek, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected September 12, 2013. Last inspected December 19, 2024.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
- Maintenance schedule, Lack of or inadequate schedule1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 19, 2024 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1256802 |
| November 24, 2016 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 994660 |
| September 12, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 853887 |
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
Solco Biomedical Co., Ltd.
FEI Number
3004941535
Address
154 Seotan-Ro, Seotan-Myeon, Pyeongtaek, Korea (the Republic of)
Country
Korea (the Republic of)
ID: f39f0f99-0c7f-47fd-b503-1bf585e5aa5d