HANPOONG PHARM CO.,LTD.
⚠️ Moderate Risk
FEI: 3004397904 • Jeonju • SOUTH KOREA
FEI Number
3004397904
Location
Jeonju
Country
SOUTH KOREAAddress
11 Guretdeul 3-Gil Deokjin-Gu, , Jeonju, , 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
EPHEDALK
The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
DIETARYING
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/9/2017 | 54EYY99HERBALS & BOTANICAL TEAS, N.E.C. | 3120EPHEDALK | Division of West Coast Imports (DWCI) |
| 6/2/2017 | 54EYY99HERBALS & BOTANICAL TEAS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 6/2/2017 | 54EYY99HERBALS & BOTANICAL TEAS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 6/2/2017 | 54EYY99HERBALS & BOTANICAL TEAS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 6/2/2017 | 54EYY99HERBALS & BOTANICAL TEAS, N.E.C. | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is HANPOONG PHARM CO.,LTD.'s FDA import refusal history?
HANPOONG PHARM CO.,LTD. (FEI: 3004397904) has 5 FDA import refusal record(s) in our database, spanning from 6/2/2017 to 6/9/2017.
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. HANPOONG PHARM CO.,LTD.'s FEI number is 3004397904.
What types of violations has HANPOONG PHARM CO.,LTD. received?
HANPOONG PHARM CO.,LTD. has been cited for 8 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 HANPOONG PHARM CO.,LTD. come from?
All FDA import refusal data for HANPOONG PHARM 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.