Nantong Egens Biotechnology Co., Ltd.
⚠️ Moderate Risk
FEI: 3006361161 • Nantong, Jiangsu • CHINA
FEI Number
3006361161
Location
Nantong, Jiangsu
Country
CHINAAddress
Building 15, 1692 Xinghu Avenue, Nantong, Jiangsu, 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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/13/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/21/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/10/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 5/4/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 5/4/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 6/19/2019 | 81MTKKIT, SAMPLE COLLECTION, HIV | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/19/2019 | 83LGADEVICE, OXIDASE TEST FOR GONORRHEA | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/19/2017 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 5/19/2017 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 4/4/2017 | 91LAFGAS CHROMATOGRAPHY, METHAMPHETAMINE | Division of Southeast Imports (DSEI) | |
| 4/4/2017 | 91LAFGAS CHROMATOGRAPHY, METHAMPHETAMINE | Division of Southeast Imports (DSEI) | |
| 10/20/2014 | 91NGETEST, LUTEINIZING HORMONE (LH), OVER THE COUNTER | Los Angeles District Office (LOS-DO) | |
| 9/10/2014 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/9/2013 | 82MTLMONITOR, TEST, HIV-1 | Seattle District Office (SEA-DO) | |
| 12/6/2011 | 91NEDKIT, TEST, MALARIA, | Seattle District Office (SEA-DO) | |
| 11/18/2008 | 85LHDDEVICE, FERTILITY DIAGNOSTIC, PROCEPTIVE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Nantong Egens Biotechnology Co., Ltd.'s FDA import refusal history?
Nantong Egens Biotechnology Co., Ltd. (FEI: 3006361161) has 16 FDA import refusal record(s) in our database, spanning from 11/18/2008 to 4/13/2021.
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. Nantong Egens Biotechnology Co., Ltd.'s FEI number is 3006361161.
What types of violations has Nantong Egens Biotechnology Co., Ltd. received?
Nantong Egens Biotechnology Co., Ltd. has been cited for 10 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 Nantong Egens Biotechnology Co., Ltd. come from?
All FDA import refusal data for Nantong Egens Biotechnology 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.