Ka Shing Brassieres Garments Ltd
⚠️ Moderate Risk
FEI: 3008763991 • Guangdong • CHINA
FEI Number
3008763991
Location
Guangdong
Country
CHINAAddress
No 10 Guyuan Industrial Area Chaozhou, , Guangdong, , 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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
Frequently Asked Questions
What is Ka Shing Brassieres Garments Ltd's FDA import refusal history?
Ka Shing Brassieres Garments Ltd (FEI: 3008763991) has 2 FDA import refusal record(s) in our database, spanning from 4/3/2012 to 5/15/2013.
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. Ka Shing Brassieres Garments Ltd's FEI number is 3008763991.
What types of violations has Ka Shing Brassieres Garments Ltd received?
Ka Shing Brassieres Garments 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 Ka Shing Brassieres Garments Ltd come from?
All FDA import refusal data for Ka Shing Brassieres Garments 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.