Beijing Medicine And Health
⚠️ Moderate Risk
FEI: 1000192319 • Beijing • CHINA
FEI Number
1000192319
Location
Beijing
Country
CHINAAddress
2 Xiao Huang Zhuang Bei Street, , 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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/25/2015 | 79FSETABLE, OPERATING-ROOM, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/17/2011 | 79GDCTABLE, OPERATING-ROOM, ELECTRICAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/12/2010 | 79FWWTABLE, OPERATING-ROOM, PNEUMATIC | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/23/2009 | 62MAA08MENTHOL (ANTI-PRURITIC) | 178COL ADDED | New York District Office (NYK-DO) |
| 6/24/2005 | 45TG99ALL OTHER PRODUCTS, NON-NUTRITIVE SWEETENERS | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 1/8/2004 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Beijing Medicine And Health's FDA import refusal history?
Beijing Medicine And Health (FEI: 1000192319) has 6 FDA import refusal record(s) in our database, spanning from 1/8/2004 to 3/25/2015.
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 Medicine And Health's FEI number is 1000192319.
What types of violations has Beijing Medicine And Health received?
Beijing Medicine And Health 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 Beijing Medicine And Health come from?
All FDA import refusal data for Beijing Medicine And Health 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.