Company
Korea (the Republic of)Wellysis CORP, Gangnam, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Wellysis CORP in Gangnam. 1 FDA inspection on record, 1 Form 483, last inspected September 10, 2026.
Company Profile
This profile covers Wellysis CORP based in Gangnam, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected September 10, 2026.
Most cited issue areas
- Design and development validation not complete prior to release of product1 inspection
- Procedures for purchasing process not documented1 inspection
- QMS software not validated prior to use or changes1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 10, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1337478 |
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
Wellysis CORP
FEI Number
3029915537
Address
8 F 425 Teheran-Ro, Gangnam, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 5f2315de-bcec-4aaf-b6d8-ea8f396acc0b