VIVACHEK BIOTECH (HANGZHOU) CO LTD
⚠️ Moderate Risk
FEI: 3013223546 • Hangzhou, Zhuji Zhejiang • CHINA
FEI Number
3013223546
Location
Hangzhou, Zhuji Zhejiang
Country
CHINAAddress
No.17 Wuzhou Road, Donghu Street, Linping District, Hangzhou, 311100 Building 2 and Building 3, No.17 Jianxing, Road, Taozhu Street, Zhuji, 311800, Hangzhou, Zhuji 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/22/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/30/2021 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 5/11/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 3/13/2017 | 82DGOIGE, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is VIVACHEK BIOTECH (HANGZHOU) CO LTD's FDA import refusal history?
VIVACHEK BIOTECH (HANGZHOU) CO LTD (FEI: 3013223546) has 4 FDA import refusal record(s) in our database, spanning from 3/13/2017 to 2/22/2022.
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. VIVACHEK BIOTECH (HANGZHOU) CO LTD's FEI number is 3013223546.
What types of violations has VIVACHEK BIOTECH (HANGZHOU) CO LTD received?
VIVACHEK BIOTECH (HANGZHOU) 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 VIVACHEK BIOTECH (HANGZHOU) CO LTD come from?
All FDA import refusal data for VIVACHEK BIOTECH (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.