Choseon Pharm & Trading Co.,Ltd
⚠️ Moderate Risk
FEI: 3011296774 • Ansan-Si, KYONGGi • SOUTH KOREA
FEI Number
3011296774
Location
Ansan-Si, KYONGGi
Country
SOUTH KOREAAddress
1229 Singil-Dong, Danwon-Gu, , Ansan-Si, KYONGGi, 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
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).
DIET INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/8/2013 | 29ACT21SOFT DRINK, GINSENG, GENSING, NONCARBONATED | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/19/2011 | 62MLK08MENTHOL (ANTI-PRURITIC) | Los Angeles District Office (LOS-DO) | |
| 2/22/2011 | 29ACT21SOFT DRINK, GINSENG, GENSING, NONCARBONATED | 251POISONOUS | Los Angeles District Office (LOS-DO) |
| 1/18/2006 | 54FBL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/18/2006 | 54FBL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 11/14/2005 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 11/14/2005 | 54FBL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Choseon Pharm & Trading Co.,Ltd's FDA import refusal history?
Choseon Pharm & Trading Co.,Ltd (FEI: 3011296774) has 7 FDA import refusal record(s) in our database, spanning from 11/14/2005 to 4/8/2013.
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. Choseon Pharm & Trading Co.,Ltd's FEI number is 3011296774.
What types of violations has Choseon Pharm & Trading Co.,Ltd received?
Choseon Pharm & Trading Co.,Ltd has been cited for 9 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 Choseon Pharm & Trading Co.,Ltd come from?
All FDA import refusal data for Choseon Pharm & Trading 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.