Beijing Medical Beauty Commerce Co,
⚠️ Moderate Risk
FEI: 3009172603 • Bjsbjs • CHINA
FEI Number
3009172603
Location
Bjsbjs
Country
CHINAAddress
(N3p) No. 15 Minsheng Rd N Zone, , Bjsbjs, , 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).
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.
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 |
|---|---|---|---|
| 10/25/2011 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Cincinnati District Office (CIN-DO) | |
| 10/25/2011 | 89ILXDIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Beijing Medical Beauty Commerce Co,'s FDA import refusal history?
Beijing Medical Beauty Commerce Co, (FEI: 3009172603) has 2 FDA import refusal record(s) in our database, spanning from 10/25/2011 to 10/25/2011.
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,'s FEI number is 3009172603.
What types of violations has Beijing Medical Beauty Commerce Co, received?
Beijing Medical Beauty Commerce Co, has been cited for 4 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, come from?
All FDA import refusal data for Beijing Medical Beauty Commerce Co, 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.