Beijing Strong Biological & Electronic Co Ltd.
⚠️ Moderate Risk
FEI: 1000324947 • Beijing, Beijing • CHINA
FEI Number
1000324947
Location
Beijing, Beijing
Country
CHINAAddress
Foreign Guest House Room 904, 4 Zhongguancun; Haidian, 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
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
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/13/2007 | 57FK74ANTI-HUMAN SERUM, ANTI C3D (MOUSE HYBRIDOMA) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Beijing Strong Biological & Electronic Co Ltd.'s FDA import refusal history?
Beijing Strong Biological & Electronic Co Ltd. (FEI: 1000324947) has 1 FDA import refusal record(s) in our database, spanning from 9/13/2007 to 9/13/2007.
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 Strong Biological & Electronic Co Ltd.'s FEI number is 1000324947.
What types of violations has Beijing Strong Biological & Electronic Co Ltd. received?
Beijing Strong Biological & Electronic Co Ltd. has been cited for 1 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 Strong Biological & Electronic Co Ltd. come from?
All FDA import refusal data for Beijing Strong Biological & Electronic 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.