K.Boeun Pharmaceutical Co.,Ltd.
⚠️ Moderate Risk
FEI: 3016756938 • Pocheon, Gyeonggi • SOUTH KOREA
FEI Number
3016756938
Location
Pocheon, Gyeonggi
Country
SOUTH KOREAAddress
114 Jangjagyeongje-Ro, Sinbung-Myeon, Pocheon, Gyeonggi, South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is K.Boeun Pharmaceutical Co.,Ltd.'s FDA import refusal history?
K.Boeun Pharmaceutical Co.,Ltd. (FEI: 3016756938) has 2 FDA import refusal record(s) in our database, spanning from 11/13/2020 to 5/8/2024.
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. K.Boeun Pharmaceutical Co.,Ltd.'s FEI number is 3016756938.
What types of violations has K.Boeun Pharmaceutical Co.,Ltd. received?
K.Boeun Pharmaceutical Co.,Ltd. has been cited for 4 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 K.Boeun Pharmaceutical Co.,Ltd. come from?
All FDA import refusal data for K.Boeun 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.