Houken (Shanghai) Co Ltd
⚠️ Moderate Risk
FEI: 3011978011 • Shanghai • CHINA
FEI Number
3011978011
Location
Shanghai
Country
CHINAAddress
Room 2102, Bldg. 5, No. 397 Jiaozhou, , Shanghai, , 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
Frequently Asked Questions
What is Houken (Shanghai) Co Ltd's FDA import refusal history?
Houken (Shanghai) Co Ltd (FEI: 3011978011) has 3 FDA import refusal record(s) in our database, spanning from 3/30/2016 to 4/28/2016.
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. Houken (Shanghai) Co Ltd's FEI number is 3011978011.
What types of violations has Houken (Shanghai) Co Ltd received?
Houken (Shanghai) 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 Houken (Shanghai) Co Ltd come from?
All FDA import refusal data for Houken (Shanghai) 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.