China Tshuaj Ntsu Ab, China
⚠️ Moderate Risk
FEI: 3008764463 • Yunnan • CHINA
FEI Number
3008764463
Location
Yunnan
Country
CHINAAddress
44 Dong Feng Rd. Wenshan, , Yunnan, , 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
BIO TOXIN
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous and deleterious substance which would ordinarily render it injurious to health. Appears to contain
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)).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/30/2011 | 54EBT99HERBALS & BOTANICAL TEAS, N.E.C. | 2981BIO TOXIN | Los Angeles District Office (LOS-DO) |
| 3/30/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 324NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 3/30/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is China Tshuaj Ntsu Ab, China's FDA import refusal history?
China Tshuaj Ntsu Ab, China (FEI: 3008764463) has 3 FDA import refusal record(s) in our database, spanning from 3/30/2011 to 3/30/2011.
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. China Tshuaj Ntsu Ab, China's FEI number is 3008764463.
What types of violations has China Tshuaj Ntsu Ab, China received?
China Tshuaj Ntsu Ab, China has been cited for 3 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 China Tshuaj Ntsu Ab, China come from?
All FDA import refusal data for China Tshuaj Ntsu Ab, China 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.