Blue Cross Bio-Medical (Beijing) Co., Ltd.
⚠️ Moderate Risk
FEI: 3005554520 • Beijing • CHINA
FEI Number
3005554520
Location
Beijing
Country
CHINAAddress
Beiqija Industry Zone, Changping 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
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).
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 LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2020 | 79GDZHANDLE, SCALPEL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/5/2015 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 5/5/2015 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 5/5/2015 | 83JSXKIT, IDENTIFICATION, NEISSERIA GONORRHOEAE | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 5/5/2015 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 12/16/2009 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/16/2009 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/15/2005 | 82MZFTEST, HIV DETECTION | Florida District Office (FLA-DO) | |
| 5/15/2003 | 57FY10ANTI-INFLUENZA VIRUS SERUM (HEMAGGLUTINATION INHIBITION TEST) (IN-VITRO DIAGNOSTIC PRODUCTS) | 71NO LICENSE | Florida District Office (FLA-DO) |
| 8/2/2002 | 57FY10ANTI-INFLUENZA VIRUS SERUM (HEMAGGLUTINATION INHIBITION TEST) (IN-VITRO DIAGNOSTIC PRODUCTS) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Blue Cross Bio-Medical (Beijing) Co., Ltd.'s FDA import refusal history?
Blue Cross Bio-Medical (Beijing) Co., Ltd. (FEI: 3005554520) has 10 FDA import refusal record(s) in our database, spanning from 8/2/2002 to 12/3/2020.
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. Blue Cross Bio-Medical (Beijing) Co., Ltd.'s FEI number is 3005554520.
What types of violations has Blue Cross Bio-Medical (Beijing) Co., Ltd. received?
Blue Cross Bio-Medical (Beijing) Co., Ltd. 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 Blue Cross Bio-Medical (Beijing) Co., Ltd. come from?
All FDA import refusal data for Blue Cross Bio-Medical (Beijing) 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.