Beijing Oriental Vison Company
⚠️ Moderate Risk
FEI: 3008750668 • Beijing, Beijing • CHINA
FEI Number
3008750668
Location
Beijing, Beijing
Country
CHINAAddress
Room 0509, 2 Rui Ou Guo Ji LI Yuantougnzhou, Beijing, Beijing, 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/15/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 9/27/2011 | 89NXUSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLING THERAPEUTIC DEEP HEAT, OVER THE COUNTER | Los Angeles District Office (LOS-DO) | |
| 2/7/2011 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Beijing Oriental Vison Company's FDA import refusal history?
Beijing Oriental Vison Company (FEI: 3008750668) has 3 FDA import refusal record(s) in our database, spanning from 2/7/2011 to 8/15/2012.
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. Beijing Oriental Vison Company's FEI number is 3008750668.
What types of violations has Beijing Oriental Vison Company received?
Beijing Oriental Vison Company 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 Beijing Oriental Vison Company come from?
All FDA import refusal data for Beijing Oriental Vison Company 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.