SHANGHAI WASETA INTERNATIONAL TRADING CO., LTD.
⚠️ Moderate Risk
FEI: 3011280203 • Shanghai City, Shanghai • CHINA
FEI Number
3011280203
Location
Shanghai City, Shanghai
Country
CHINAAddress
Golden Eagle Edifice B Room, NO. 1518 Minsheng Road; Pudong New Area, Shanghai City, 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
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/29/2015 | 54YBR09GERMANIUM (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 251POISONOUS | New Orleans District Office (NOL-DO) |
| 10/20/2014 | 54YYS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 10/16/2014 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 10/16/2014 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 12/12/2013 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 11/6/2013 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 6/12/2013 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 260FALSE | Seattle District Office (SEA-DO) |
| 4/26/2013 | 62HAS99ANTI-MICROBIAL N.E.C. | New Orleans District Office (NOL-DO) | |
| 6/20/2012 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/7/2012 | 66VCR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2009 | 54FBF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | New Orleans District Office (NOL-DO) |
| 11/8/2007 | 60CAR09PHENYLEPHRINE HCL (ADRENERGIC) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is SHANGHAI WASETA INTERNATIONAL TRADING CO., LTD.'s FDA import refusal history?
SHANGHAI WASETA INTERNATIONAL TRADING CO., LTD. (FEI: 3011280203) has 12 FDA import refusal record(s) in our database, spanning from 11/8/2007 to 10/29/2015.
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. SHANGHAI WASETA INTERNATIONAL TRADING CO., LTD.'s FEI number is 3011280203.
What types of violations has SHANGHAI WASETA INTERNATIONAL TRADING CO., LTD. received?
SHANGHAI WASETA INTERNATIONAL TRADING CO., LTD. has been cited for 7 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 WASETA INTERNATIONAL TRADING CO., LTD. come from?
All FDA import refusal data for SHANGHAI WASETA 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.