Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)
⚠️ Moderate Risk
FEI: 3010728912 • Wenzhou, Zhejiang • CHINA
FEI Number
3010728912
Location
Wenzhou, Zhejiang
Country
CHINAAddress
Binhai Industrial Park, No. 555 The 8th Binhai Rd.; Longwan District, Wenzhou, 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.
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).
Refusal History
Frequently Asked Questions
What is Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)'s FDA import refusal history?
Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) (FEI: 3010728912) has 2 FDA import refusal record(s) in our database, spanning from 7/11/2006 to 9/12/2013.
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. Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)'s FEI number is 3010728912.
What types of violations has Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) received?
Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) has been cited for 2 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 Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) come from?
All FDA import refusal data for Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) 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.