KM PHARMACEUTICAL CO., LTD.
✅ Low Risk
FEI: 3010164172 • Pyeongtaek, Gyeonggi • SOUTH KOREA
FEI Number
3010164172
Location
Pyeongtaek, Gyeonggi
Country
SOUTH KOREAAddress
121 Pyeongtaekhangro268beon-Gil, Poseung-Eup, Pyeongtaek, Gyeonggi, South Korea
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
Frequently Asked Questions
What is KM PHARMACEUTICAL CO., LTD.'s FDA import refusal history?
KM PHARMACEUTICAL CO., LTD. (FEI: 3010164172) has 1 FDA import refusal record(s) in our database, spanning from 9/30/2022 to 9/30/2022.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. KM PHARMACEUTICAL CO., LTD.'s FEI number is 3010164172.
What types of violations has KM PHARMACEUTICAL CO., LTD. received?
KM PHARMACEUTICAL CO., LTD. has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about KM PHARMACEUTICAL CO., LTD. come from?
All FDA import refusal data for KM PHARMACEUTICAL CO., LTD. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.