Yiwu Tonsen Imp & Export Co., Ltd.
⚠️ High Risk
FEI: 3005805174 • Yiwu, Zhejiang • CHINA
FEI Number
3005805174
Location
Yiwu, Zhejiang
Country
CHINAAddress
Rm 401 Unit 2 Bldg 56, Yongshen Area, Yiwu, Zhejiang, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
PB-FOOD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, lead, which may render it injurious to health.
CONTAINER
The container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/8/2019 | 52AIE26CUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Division of Northeast Imports (DNEI) |
| 4/7/2016 | 52AIE99KITCHEN AND TABLEWARE, N.E.C., (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Division of Northern Border Imports (DNBI) |
| 4/7/2016 | 52AIE26CUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Division of Northern Border Imports (DNBI) |
| 4/7/2016 | 52AIE29PLATTERS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Division of Northern Border Imports (DNBI) |
| 4/7/2016 | 52AIE29PLATTERS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Division of Northern Border Imports (DNBI) |
| 2/6/2015 | 52AIE28PLATES, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Minneapolis District Office (MIN-DO) |
| 2/6/2015 | 52AIE26CUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Minneapolis District Office (MIN-DO) |
| 10/23/2014 | 52AIE26CUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE) | 171CONTAINER | Minneapolis District Office (MIN-DO) |
| 7/18/2014 | 52AIE28PLATES, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE) | 3400PB-FOOD | Minneapolis District Office (MIN-DO) |
| 7/18/2014 | 52AIE26CUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE) | 3400PB-FOOD | Minneapolis District Office (MIN-DO) |
| 3/28/2014 | 52AIE26CUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Minneapolis District Office (MIN-DO) |
| 3/28/2014 | 52AIE29PLATTERS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Minneapolis District Office (MIN-DO) |
| 10/18/2012 | 52AIE26CUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE) | 3400PB-FOOD | Minneapolis District Office (MIN-DO) |
| 10/16/2012 | 52AIE26CUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Minneapolis District Office (MIN-DO) |
| 10/6/2011 | 52AIE26CUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Minneapolis District Office (MIN-DO) |
| 10/5/2011 | 52AIE26CUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Minneapolis District Office (MIN-DO) |
| 5/18/2011 | 52AIE29PLATTERS (FOODWARE, COOKWARE & TABLEWARE) | 171CONTAINER | Minneapolis District Office (MIN-DO) |
| 3/14/2011 | 52AJE26CUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Southwest Import District Office (SWI-DO) |
| 10/13/2010 | 52AJE24MIXED SETS/SERVICE SETS (NOTE: USE SUBCLASS J, L, N, OR P ONLY) FOODWARE, COOKWARE & TABLEWARE | 238UNSAFE ADD | Seattle District Office (SEA-DO) |
| 10/1/2010 | 52AJE50TEA KETTLE (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Cincinnati District Office (CIN-DO) |
| 9/11/2008 | 52AJE32COFFEE/TEA POTS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Seattle District Office (SEA-DO) |
| 5/16/2007 | 76EFWTOOTHBRUSH, MANUAL | Seattle District Office (SEA-DO) | |
| 5/16/2007 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Seattle District Office (SEA-DO) |
| 5/16/2007 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Seattle District Office (SEA-DO) |
| 5/16/2007 | 52AIE32COFFEE/TEA POTS (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Yiwu Tonsen Imp & Export Co., Ltd.'s FDA import refusal history?
Yiwu Tonsen Imp & Export Co., Ltd. (FEI: 3005805174) has 25 FDA import refusal record(s) in our database, spanning from 5/16/2007 to 8/8/2019.
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. Yiwu Tonsen Imp & Export Co., Ltd.'s FEI number is 3005805174.
What types of violations has Yiwu Tonsen Imp & Export Co., Ltd. received?
Yiwu Tonsen Imp & Export Co., Ltd. has been cited for 6 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 Yiwu Tonsen Imp & Export Co., Ltd. come from?
All FDA import refusal data for Yiwu Tonsen Imp & Export 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.