Company
Korea (the Republic of)Medexel Co., Ltd., Anseong, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Medexel Co., Ltd. in Anseong. 2 FDA inspections on record, 1 Form 483, last inspected February 27, 2025.
Company Profile
This profile covers Medexel Co., Ltd. based in Anseong, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected May 26, 2016. Last inspected February 27, 2025.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- DHR documentation of label release {see also 820.184}1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 27, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1262862 |
| May 26, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 973067 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Medexel Co., Ltd.
FEI Number
3003589279
Address
252 Geumgwangosan-Ro, Geumgwang-Myeon, Anseong, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 1156ff5c-dacf-400b-8da3-094170830bf1