Shanghai Tianyuan Plant Products Co., Ltd.
⚠️ Moderate Risk
FEI: 3010061323 • Shanghai, Shanghai • CHINA
FEI Number
3010061323
Location
Shanghai, Shanghai
Country
CHINAAddress
18 Hexiang Road, , 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).
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
PESTICIDE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:
PESTICIDE2
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/11/2018 | 54YBR04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | 241PESTICIDE | Division of West Coast Imports (DWCI) |
| 1/23/2015 | 54FBY12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 3721PESTICIDE2 | Division of West Coast Imports (DWCI) |
| 8/1/2014 | 54YAZ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | San Francisco District Office (SAN-DO) |
| 11/19/2012 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 11/19/2012 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 11/19/2012 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 11/19/2012 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Shanghai Tianyuan Plant Products Co., Ltd.'s FDA import refusal history?
Shanghai Tianyuan Plant Products Co., Ltd. (FEI: 3010061323) has 7 FDA import refusal record(s) in our database, spanning from 11/19/2012 to 1/11/2018.
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 Tianyuan Plant Products Co., Ltd.'s FEI number is 3010061323.
What types of violations has Shanghai Tianyuan Plant Products Co., Ltd. received?
Shanghai Tianyuan Plant Products 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 Tianyuan Plant Products Co., Ltd. come from?
All FDA import refusal data for Shanghai Tianyuan Plant Products 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.