Huzhou Sifeng Biochem Co Ltd
⚠️ Moderate Risk
FEI: 3009254404 • Huzhoushi, Zhejiangsheng • CHINA
FEI Number
3009254404
Location
Huzhoushi, Zhejiangsheng
Country
CHINAAddress
Rm A 119 No 699 Qingtonglu, , Huzhoushi, Zhejiangsheng, 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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 Huzhou Sifeng Biochem Co Ltd's FDA import refusal history?
Huzhou Sifeng Biochem Co Ltd (FEI: 3009254404) has 1 FDA import refusal record(s) in our database, spanning from 3/9/2016 to 3/9/2016.
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. Huzhou Sifeng Biochem Co Ltd's FEI number is 3009254404.
What types of violations has Huzhou Sifeng Biochem Co Ltd received?
Huzhou Sifeng Biochem 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 Huzhou Sifeng Biochem Co Ltd come from?
All FDA import refusal data for Huzhou Sifeng Biochem 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.