Beijing Medical Beauty Commerce Co Ltd
⚠️ Moderate Risk
FEI: 3009127773 • Daxing District, Beijing • CHINA
FEI Number
3009127773
Location
Daxing District, Beijing
Country
CHINAAddress
Yard 6, East Road, Nanchang 1st Villiage, Jingong Town, Daxing District, 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).
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 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.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2014 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Cincinnati District Office (CIN-DO) | |
| 12/4/2012 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | Cincinnati District Office (CIN-DO) | |
| 2/16/2012 | 95RHLLASER THERAPY PRODUCT | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
| 10/7/2011 | 79MVFSYSTEM, LASER, PHOTODYNAMIC THERAPY | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Beijing Medical Beauty Commerce Co Ltd's FDA import refusal history?
Beijing Medical Beauty Commerce Co Ltd (FEI: 3009127773) has 4 FDA import refusal record(s) in our database, spanning from 10/7/2011 to 10/16/2014.
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 Medical Beauty Commerce Co Ltd's FEI number is 3009127773.
What types of violations has Beijing Medical Beauty Commerce Co Ltd received?
Beijing Medical Beauty Commerce Co Ltd has been cited for 7 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 Medical Beauty Commerce Co Ltd come from?
All FDA import refusal data for Beijing Medical Beauty Commerce 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.