Zhejiang Qianfei Enterprise Co. Ltd.
⚠️ Moderate Risk
FEI: 3006143547 • Jinhua, Zhejiang • CHINA
FEI Number
3006143547
Location
Jinhua, Zhejiang
Country
CHINAAddress
No 173 Wulian Road, Yiwu, Jinhua, 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
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).
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 Zhejiang Qianfei Enterprise Co. Ltd.'s FDA import refusal history?
Zhejiang Qianfei Enterprise Co. Ltd. (FEI: 3006143547) has 3 FDA import refusal record(s) in our database, spanning from 12/21/2012 to 11/25/2013.
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 Qianfei Enterprise Co. Ltd.'s FEI number is 3006143547.
What types of violations has Zhejiang Qianfei Enterprise Co. Ltd. received?
Zhejiang Qianfei Enterprise Co. Ltd. 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 Qianfei Enterprise Co. Ltd. come from?
All FDA import refusal data for Zhejiang Qianfei Enterprise 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.