Changshu Huashun Clothing Co Ltd
⚠️ Moderate Risk
FEI: 3007590008 • Changshu City • CHINA
FEI Number
3007590008
Location
Changshu City
Country
CHINAAddress
188 Zhiwang Rd, , Changshu City, , 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
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).
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/31/2011 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 3/31/2011 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 5/4/2010 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Changshu Huashun Clothing Co Ltd's FDA import refusal history?
Changshu Huashun Clothing Co Ltd (FEI: 3007590008) has 3 FDA import refusal record(s) in our database, spanning from 5/4/2010 to 3/31/2011.
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. Changshu Huashun Clothing Co Ltd's FEI number is 3007590008.
What types of violations has Changshu Huashun Clothing Co Ltd received?
Changshu Huashun Clothing Co Ltd has been cited for 3 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 Changshu Huashun Clothing Co Ltd come from?
All FDA import refusal data for Changshu Huashun Clothing 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.