Jiangsu Soho Int'L Gp Yangzhou Co.
⚠️ Moderate Risk
FEI: 3005920742 • Jiangsu • CHINA
FEI Number
3005920742
Location
Jiangsu
Country
CHINAAddress
No.628 Yangzijiang Middle Roadyangzhou, , Jiangsu, , 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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.
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 |
|---|---|---|---|
| 1/28/2010 | 76NXZKIT, DENTAL HYGIENE | 310POISONOUS | San Francisco District Office (SAN-DO) |
| 12/15/2009 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/4/2009 | 76NXZKIT, DENTAL HYGIENE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 11/4/2008 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 11/4/2008 | 76EFWTOOTHBRUSH, MANUAL | Los Angeles District Office (LOS-DO) | |
| 12/5/2007 | 76NXZKIT, DENTAL HYGIENE | 310POISONOUS | Los Angeles District Office (LOS-DO) |
| 10/12/2007 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Jiangsu Soho Int'L Gp Yangzhou Co.'s FDA import refusal history?
Jiangsu Soho Int'L Gp Yangzhou Co. (FEI: 3005920742) has 7 FDA import refusal record(s) in our database, spanning from 10/12/2007 to 1/28/2010.
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 Int'L Gp Yangzhou Co.'s FEI number is 3005920742.
What types of violations has Jiangsu Soho Int'L Gp Yangzhou Co. received?
Jiangsu Soho Int'L Gp Yangzhou Co. 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 Jiangsu Soho Int'L Gp Yangzhou Co. come from?
All FDA import refusal data for Jiangsu Soho Int'L Gp 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.