Han UL Trading Co., Ltd.
⚠️ Moderate Risk
FEI: 3003705646 • Pusan • SOUTH KOREA
FEI Number
3003705646
Location
Pusan
Country
SOUTH KOREAAddress
#6 Fl., Hyundai Towe B/d 690-4, Junpo-1-dong, Pusanjin-gu, Pusan, , 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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/19/2007 | 73BTKSTRAP, HEAD, GAS MASK | Los Angeles District Office (LOS-DO) | |
| 3/19/2007 | 80KYRBAG, ICE | Los Angeles District Office (LOS-DO) | |
| 8/10/2006 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 3/8/2006 | 80FRISCALE, STAND-ON, PATIENT | Los Angeles District Office (LOS-DO) | |
| 3/8/2006 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Los Angeles District Office (LOS-DO) | |
| 2/27/2006 | 84MVVDEVICE, ACUPRESSURE | 3081INVDEVICE | Los Angeles District Office (LOS-DO) |
| 7/12/2005 | 89INIVEHICLE, MOTORIZED 3-WHEELED | Los Angeles District Office (LOS-DO) | |
| 10/23/2004 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/21/2002 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Los Angeles District Office (LOS-DO) | |
| 5/24/2002 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Los Angeles District Office (LOS-DO) | |
| 4/26/2002 | 53YY02COSMETIC BRUSH (OTHER COSMETIC AND COSMETIC PRODUCTS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 12/18/2001 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Han UL Trading Co., Ltd.'s FDA import refusal history?
Han UL Trading Co., Ltd. (FEI: 3003705646) has 12 FDA import refusal record(s) in our database, spanning from 12/18/2001 to 3/19/2007.
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. Han UL Trading Co., Ltd.'s FEI number is 3003705646.
What types of violations has Han UL Trading Co., Ltd. received?
Han UL Trading 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 Han UL Trading Co., Ltd. come from?
All FDA import refusal data for Han UL 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.