JIANGSU SOHO INTERNATIONAL GROUP YANGZHOU CO.
⚠️ Moderate Risk
FEI: 3007485188 • Yangzhou • CHINA
FEI Number
3007485188
Location
Yangzhou
Country
CHINAAddress
8th Fl./Tower 4, W. City Superior Bldg. Plaza, 303 Wen Hui W. Road, Yangzhou, , 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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
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.
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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 |
|---|---|---|---|
| 3/16/2023 | 76NXZKIT, DENTAL HYGIENE | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 1/14/2020 | 76NXZKIT, DENTAL HYGIENE | Division of Southeast Imports (DSEI) | |
| 1/14/2020 | 76NXZKIT, DENTAL HYGIENE | Division of Southeast Imports (DSEI) | |
| 1/14/2020 | 76NXZKIT, DENTAL HYGIENE | Division of Southeast Imports (DSEI) | |
| 10/27/2014 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 197COSM COLOR | San Francisco District Office (SAN-DO) |
| 3/1/2012 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | San Francisco District Office (SAN-DO) | |
| 1/6/2012 | 62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Baltimore District Office (BLT-DO) | |
| 12/20/2011 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 197COSM COLOR | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is JIANGSU SOHO INTERNATIONAL GROUP YANGZHOU CO.'s FDA import refusal history?
JIANGSU SOHO INTERNATIONAL GROUP YANGZHOU CO. (FEI: 3007485188) has 8 FDA import refusal record(s) in our database, spanning from 12/20/2011 to 3/16/2023.
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. JIANGSU SOHO INTERNATIONAL GROUP YANGZHOU CO.'s FEI number is 3007485188.
What types of violations has JIANGSU SOHO INTERNATIONAL GROUP YANGZHOU CO. received?
JIANGSU SOHO INTERNATIONAL GROUP YANGZHOU CO. 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 JIANGSU SOHO INTERNATIONAL GROUP YANGZHOU CO. come from?
All FDA import refusal data for JIANGSU SOHO INTERNATIONAL GROUP YANGZHOU CO. 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.