Company
Korea (the Republic of)DK MEDICAL SYSTEMS CO., LTD., Pyeongtaek, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for DK MEDICAL SYSTEMS CO., LTD. in Pyeongtaek. 2 FDA inspections on record, 2 Form 483s, last inspected September 17, 2026.
Company Profile
This profile covers DK MEDICAL SYSTEMS CO., LTD. based in Pyeongtaek, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected November 2, 2023. Last inspected September 17, 2026.
Most cited issue areas
- Complaint handling procedures lack required elements1 inspection
- Design review - Lack of or inadequate procedures1 inspection
- Design verification - documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 17, 2026 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1335994 |
| November 2, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1223665 |
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
DK MEDICAL SYSTEMS CO., LTD.
FEI Number
3014403439
Address
52 Chupalsandan 1-Gil, Paengseong-Eup, Pyeongtaek, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 7f4c670e-4272-47d8-8fce-70e1bfe51dda