T & D Overseas Buying Co., Ltd
⚠️ Moderate Risk
FEI: 3003486011 • Shenzhen • CHINA
FEI Number
3003486011
Location
Shenzhen
Country
CHINAAddress
2a, No. 3 Building Co., Lizhu Garden,, , Shenzhen, , 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
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.
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 |
|---|---|---|---|
| 9/24/2015 | 53YF99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | New York District Office (NYK-DO) | |
| 9/24/2015 | 53YF99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | New York District Office (NYK-DO) | |
| 9/4/2014 | 89ITQJOINT, KNEE, EXTERNAL BRACE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is T & D Overseas Buying Co., Ltd's FDA import refusal history?
T & D Overseas Buying Co., Ltd (FEI: 3003486011) has 3 FDA import refusal record(s) in our database, spanning from 9/4/2014 to 9/24/2015.
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. T & D Overseas Buying Co., Ltd's FEI number is 3003486011.
What types of violations has T & D Overseas Buying Co., Ltd received?
T & D Overseas Buying 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 T & D Overseas Buying Co., Ltd come from?
All FDA import refusal data for T & D Overseas Buying 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.