Shanghai Tiantan International Trading Co.,Ltd.
⚠️ Moderate Risk
FEI: 3003855929 • Shanghai, Shanghai • CHINA
FEI Number
3003855929
Location
Shanghai, Shanghai
Country
CHINAAddress
F/7-8, 188 Jiangninglu, Shanghai, Shanghai, 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
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).
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).
DIET INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/9/2006 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 7/19/2005 | 31KFT02TEA, GREEN | Division of West Coast Imports (DWCI) | |
| 7/19/2005 | 66VBI99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 7/19/2005 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 7/19/2005 | 66VBI99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 7/19/2005 | 66VBI99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Shanghai Tiantan International Trading Co.,Ltd.'s FDA import refusal history?
Shanghai Tiantan International Trading Co.,Ltd. (FEI: 3003855929) has 6 FDA import refusal record(s) in our database, spanning from 7/19/2005 to 8/9/2006.
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. Shanghai Tiantan International Trading Co.,Ltd.'s FEI number is 3003855929.
What types of violations has Shanghai Tiantan International Trading Co.,Ltd. received?
Shanghai Tiantan International Trading Co.,Ltd. has been cited for 5 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 Shanghai Tiantan International Trading Co.,Ltd. come from?
All FDA import refusal data for Shanghai Tiantan International 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.