Sean & Stephan Corporation
⚠️ Moderate Risk
FEI: 3003496024 • Zhong Shan City • CHINA
FEI Number
3003496024
Location
Zhong Shan City
Country
CHINAAddress
First Industry Zone Tanzhou Town, , Zhong Shan City, , 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
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/23/2013 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 5/23/2013 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 5/23/2013 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sean & Stephan Corporation's FDA import refusal history?
Sean & Stephan Corporation (FEI: 3003496024) has 3 FDA import refusal record(s) in our database, spanning from 5/23/2013 to 5/23/2013.
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. Sean & Stephan Corporation's FEI number is 3003496024.
What types of violations has Sean & Stephan Corporation received?
Sean & Stephan Corporation has been cited for 6 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 Sean & Stephan Corporation come from?
All FDA import refusal data for Sean & Stephan Corporation 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.