Changzhou Dahua Import And Export
⚠️ Moderate Risk
FEI: 3007002565 • Changzhou, Jiangsu Province • CHINA
FEI Number
3007002565
Location
Changzhou, Jiangsu Province
Country
CHINAAddress
Hengyuan Bldg. F/8-10, No 180 Guahne West Road, Changzhou, Jiangsu Province, 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.
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
Refusal History
Frequently Asked Questions
What is Changzhou Dahua Import And Export's FDA import refusal history?
Changzhou Dahua Import And Export (FEI: 3007002565) has 2 FDA import refusal record(s) in our database, spanning from 4/2/2008 to 7/21/2008.
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. Changzhou Dahua Import And Export's FEI number is 3007002565.
What types of violations has Changzhou Dahua Import And Export received?
Changzhou Dahua Import And Export 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 Changzhou Dahua Import And Export come from?
All FDA import refusal data for Changzhou Dahua Import And Export 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.