Zhong Shan Hua Wei Fashionable Dress Co
⚠️ Moderate Risk
FEI: 1000141931 • Zhong Shan • CHINA
FEI Number
1000141931
Location
Zhong Shan
Country
CHINAAddress
The Second Industrial Centre Of Sha Xi, , Zhong Shan, , 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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 10/8/2002 | 66VBE99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 10/8/2002 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 10/8/2002 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Zhong Shan Hua Wei Fashionable Dress Co's FDA import refusal history?
Zhong Shan Hua Wei Fashionable Dress Co (FEI: 1000141931) has 3 FDA import refusal record(s) in our database, spanning from 10/8/2002 to 10/8/2002.
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. Zhong Shan Hua Wei Fashionable Dress Co's FEI number is 1000141931.
What types of violations has Zhong Shan Hua Wei Fashionable Dress Co received?
Zhong Shan Hua Wei Fashionable Dress 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 Zhong Shan Hua Wei Fashionable Dress Co come from?
All FDA import refusal data for Zhong Shan Hua Wei Fashionable Dress 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.