Abon Biopharm (Hangzhou) Co., Ltd.
⚠️ Moderate Risk
FEI: 3005641941 • Hangzhou, Zhejiang • CHINA
FEI Number
3005641941
Location
Hangzhou, Zhejiang
Country
CHINAAddress
#198, #12 Street East, Hangzhou, Economic & Tech. Development Area, Hangzhou, Zhejiang, 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).
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.
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.
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 |
|---|---|---|---|
| 6/18/2012 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 10/13/2009 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 12/30/2008 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Seattle District Office (SEA-DO) | |
| 8/3/2006 | 75MGXTEST SYSTEM, FOR DRUGS OF ABUSE | Seattle District Office (SEA-DO) | |
| 8/3/2006 | 75MGXTEST SYSTEM, FOR DRUGS OF ABUSE | Seattle District Office (SEA-DO) | |
| 8/3/2006 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Abon Biopharm (Hangzhou) Co., Ltd.'s FDA import refusal history?
Abon Biopharm (Hangzhou) Co., Ltd. (FEI: 3005641941) has 6 FDA import refusal record(s) in our database, spanning from 8/3/2006 to 6/18/2012.
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. Abon Biopharm (Hangzhou) Co., Ltd.'s FEI number is 3005641941.
What types of violations has Abon Biopharm (Hangzhou) Co., Ltd. received?
Abon Biopharm (Hangzhou) Co., Ltd. has been cited for 5 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 Abon Biopharm (Hangzhou) Co., Ltd. come from?
All FDA import refusal data for Abon Biopharm (Hangzhou) 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.