Company
Korea (the Republic of)RECENSMEDICAL INC, Hwaseong, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for RECENSMEDICAL INC in Hwaseong. 2 FDA inspections on record, 1 Form 483, last inspected September 03, 2026.
Company Profile
This profile covers RECENSMEDICAL INC based in Hwaseong, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 11, 2024. Last inspected September 3, 2026.
Most cited issue areas
- Procedures for validation of processes lack required elements1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 3, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1337210 |
| January 11, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1228275 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
RECENSMEDICAL INC
FEI Number
3015351183
Address
64-10 Dongtangiheung-Ro, Hwaseong, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 86e9d371-62d8-44f8-b6ae-fbe450e2b488