Zhejiang Orient Gene Biotech
⚠️ Moderate Risk
FEI: 3008517993 • Huzhou, Zhejiang • CHINA
FEI Number
3008517993
Location
Huzhou, Zhejiang
Country
CHINAAddress
3787 East Yangguang Avenue Dipu Street, Anji, , Huzhou, 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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/18/2023 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 3/23/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/11/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/7/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/7/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/15/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/27/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/14/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 9/3/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 237NO PMA | Division of Southeast Imports (DSEI) |
| 5/12/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 9/5/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 7/22/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 5/19/2020 | 83OTGNON-SARS CORONAVIRUS MULTIPLEX NUCLEIC ACID ASSAY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/5/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 4/25/2019 | 57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/10/2012 | 91NGLTEST, OPIATES, OVER THE COUNTER | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Zhejiang Orient Gene Biotech's FDA import refusal history?
Zhejiang Orient Gene Biotech (FEI: 3008517993) has 17 FDA import refusal record(s) in our database, spanning from 10/10/2012 to 1/18/2023.
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. Zhejiang Orient Gene Biotech's FEI number is 3008517993.
What types of violations has Zhejiang Orient Gene Biotech received?
Zhejiang Orient Gene Biotech 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 Zhejiang Orient Gene Biotech come from?
All FDA import refusal data for Zhejiang Orient Gene Biotech 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.