Company
Korea (the Republic of)KM PHARMACEUTICAL CO., LTD., Pyeongtaek, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for KM PHARMACEUTICAL CO., LTD. in Pyeongtaek. 2 FDA inspections on record, 2 Form 483s, last inspected September 18, 2026.
Company Profile
This profile covers KM PHARMACEUTICAL 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 February 22, 2019. Last inspected September 18, 2026.
Most cited issue areas
- Following/documenting laboratory controls1 inspection
- Items to cover on annual reviews1 inspection
- Labeling control records including specimens or copies1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 18, 2026 | Not classified | Human Drugs | 1342994 |
| February 22, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1080318 |
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
KM PHARMACEUTICAL CO., LTD.
FEI Number
3010164172
Address
121 Pyeongtaekangro268beon-Gil, Poseung-Eup, Pyeongtaek, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 2659f22e-8bc9-406e-85dd-11527c764a1f