ABNOVA TAIWAN CORPORATION
⚠️ Moderate Risk
FEI: 3007539499 • Taipei, Taipei • TAIWAN
FEI Number
3007539499
Location
Taipei, Taipei
Country
TAIWANAddress
9th Fl., No.108, Jhouzih St., Neihu District, Taipei, Taipei, Taiwan
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 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.
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).
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.
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).
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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/21/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/15/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/10/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/2/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/2/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/2/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/28/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/26/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/26/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/20/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/20/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/20/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/20/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/15/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/8/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Northern Border Imports (DNBI) | |
| 4/30/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/19/2018 | 57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 223FALSE | Division of Southeast Imports (DSEI) |
| 9/19/2018 | 88OTURESEARCH USE ONLY/PATHOLOGY | 223FALSE | Division of Southeast Imports (DSEI) |
| 9/19/2018 | 88OTURESEARCH USE ONLY/PATHOLOGY | 223FALSE | Division of Southeast Imports (DSEI) |
| 9/19/2018 | 88OTURESEARCH USE ONLY/PATHOLOGY | 223FALSE | Division of Southeast Imports (DSEI) |
| 9/19/2018 | 88OTURESEARCH USE ONLY/PATHOLOGY | 223FALSE | Division of Southeast Imports (DSEI) |
| 9/19/2018 | 88OTURESEARCH USE ONLY/PATHOLOGY | 223FALSE | Division of Southeast Imports (DSEI) |
| 7/2/2008 | 75MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT | San Francisco District Office (SAN-DO) | |
| 10/5/2007 | 88NTRIMMUNOHISTOCHEMICAL REAGENT, ANITBODY (MONOCLONAL OR POLYCLONAL) TO P63 PROTEIN IN NUCLEUS OF PROSTA | San Francisco District Office (SAN-DO) | |
| 4/25/2007 | 57EY10TUBERCULIN, PURIFIED PROTEIN DERIVATIVE | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 4/14/2007 | 57FK53REAGENT RED BLOOD CELLS (IN-VITRO DIAGNOSTIC PRODUCTS) | 71NO LICENSE | San Francisco District Office (SAN-DO) |
| 4/4/2007 | 57FY53REAGENT RED BLOOD CELLS (IN-VITRO DIAGNOSTIC PRODUCTS) | 71NO LICENSE | San Francisco District Office (SAN-DO) |
| 3/15/2007 | 88LDTREAGENT, GENERAL PURPOSE | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 3/2/2007 | 88LDTREAGENT, GENERAL PURPOSE | San Francisco District Office (SAN-DO) | |
| 2/17/2007 | 82KTQREAGENT, COMPLEMENT | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is ABNOVA TAIWAN CORPORATION's FDA import refusal history?
ABNOVA TAIWAN CORPORATION (FEI: 3007539499) has 51 FDA import refusal record(s) in our database, spanning from 2/17/2007 to 8/21/2020.
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. ABNOVA TAIWAN CORPORATION's FEI number is 3007539499.
What types of violations has ABNOVA TAIWAN CORPORATION received?
ABNOVA TAIWAN CORPORATION 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 ABNOVA TAIWAN CORPORATION come from?
All FDA import refusal data for ABNOVA TAIWAN CORPORATION 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.