Yiwu Lier Import And Export Co Ltd
⚠️ Moderate Risk
FEI: 3007037510 • Zhejiang Province • CHINA
FEI Number
3007037510
Location
Zhejiang Province
Country
CHINAAddress
4-5 Floor Chouzhou North Road Yiwu City, , Zhejiang Province, , China
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/19/2010 | 61H99ANTI-BACTERIAL, N.E.C. | Baltimore District Office (BLT-DO) | |
| 5/19/2010 | 61H99ANTI-BACTERIAL, N.E.C. | Baltimore District Office (BLT-DO) | |
| 5/19/2010 | 61H99ANTI-BACTERIAL, N.E.C. | Baltimore District Office (BLT-DO) | |
| 5/19/2010 | 61H99ANTI-BACTERIAL, N.E.C. | 472NO ENGLISH | Baltimore District Office (BLT-DO) |
| 5/19/2010 | 53I01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Baltimore District Office (BLT-DO) | |
| 5/19/2010 | 61H99ANTI-BACTERIAL, N.E.C. | Baltimore District Office (BLT-DO) | |
| 10/2/2008 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 10/2/2008 | 53GI05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 10/2/2008 | 53FC01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 10/2/2008 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Baltimore District Office (BLT-DO) | |
| 10/2/2008 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Yiwu Lier Import And Export Co Ltd's FDA import refusal history?
Yiwu Lier Import And Export Co Ltd (FEI: 3007037510) has 11 FDA import refusal record(s) in our database, spanning from 10/2/2008 to 5/19/2010.
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 Lier Import And Export Co Ltd's FEI number is 3007037510.
What types of violations has Yiwu Lier Import And Export Co Ltd received?
Yiwu Lier Import And Export 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 Yiwu Lier Import And Export Co Ltd come from?
All FDA import refusal data for Yiwu Lier Import And 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.