Hangzhou Changtian Co Ltd
⚠️ Moderate Risk
FEI: 3005982847 • Zhejiang • CHINA
FEI Number
3005982847
Location
Zhejiang
Country
CHINAAddress
No 48 Huanggu Shan Rd, , Zhejiang, , 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
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.
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.
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
Frequently Asked Questions
What is Hangzhou Changtian Co Ltd's FDA import refusal history?
Hangzhou Changtian Co Ltd (FEI: 3005982847) has 1 FDA import refusal record(s) in our database, spanning from 5/1/2007 to 5/1/2007.
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. Hangzhou Changtian Co Ltd's FEI number is 3005982847.
What types of violations has Hangzhou Changtian Co Ltd received?
Hangzhou Changtian 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 Hangzhou Changtian Co Ltd come from?
All FDA import refusal data for Hangzhou Changtian 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.