Hangzhou Clongene Biotech Co., Ltd.

⚠️ High Risk

FEI: 3009414546 • Hangzhou, Zhejiang • CHINA

FEI

FEI Number

3009414546

📍

Location

Hangzhou, Zhejiang

🇨🇳

Country

CHINA

🏢

Address

No. 1 Yuchang Road, Yuhang, Hangzhou, Zhejiang, China

High Risk

FDA Import Risk Assessment

61.0

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

5/29/2025

Latest Refusal

3/26/2012

Earliest Refusal

Score Breakdown

Violation Severity

62.4×40%

Refusal Volume

54.7×30%

Recency

87.3×20%

Frequency

22.0×10%

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

Violation Summary

50827×

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.

1184×

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).

24804×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

32803×

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.

3413×

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).

161×

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.

3331×

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.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

2371×

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).

Refusal History

Date	Product	Violations	Division
5/29/2025	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
3/31/2025	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
10/8/2024	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	2480RXPERSONAL 508NO 510(K)	Division of Southeast Imports (DSEI)
4/7/2022	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	508NO 510(K)	Division of Southeast Imports (DSEI)
4/1/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
3/10/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
3/2/2022	83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE	508NO 510(K)	Division of Northern Border Imports (DNBI)
3/1/2022	83QMVA DEVICE TO DETECT AND IDENTIFY MICROBIAL AGENTS IN HUMAN CLINICAL SPECIMENS THAT CAUSE FEVER	508NO 510(K)	Division of Southeast Imports (DSEI)
2/28/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
2/18/2022	83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE	508NO 510(K)	Division of Northern Border Imports (DNBI)
11/19/2021	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
10/28/2021	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	341REGISTERED 472NO ENGLISH 508NO 510(K)	Division of Southeast Imports (DSEI)
10/25/2021	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	508NO 510(K)	Division of Southeast Imports (DSEI)
7/1/2021	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2020	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	2480RXPERSONAL	Division of Southeast Imports (DSEI)
8/29/2020	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	508NO 510(K)	Division of Southeast Imports (DSEI)
8/27/2020	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
8/20/2020	83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	508NO 510(K)	Division of Southeast Imports (DSEI)
8/12/2020	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	508NO 510(K)	Division of Southeast Imports (DSEI)
7/25/2020	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	508NO 510(K)	Division of Southeast Imports (DSEI)
6/22/2020	83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	508NO 510(K)	Division of Southeast Imports (DSEI)
6/12/2020	83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	508NO 510(K)	Division of Southeast Imports (DSEI)
6/10/2020	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	333LACKS FIRM 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	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	16DIRECTIONS 508NO 510(K)	Division of Southeast Imports (DSEI)
5/29/2020	83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	508NO 510(K)	Division of Southeast Imports (DSEI)
5/6/2020	83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	2480RXPERSONAL 508NO 510(K)	Division of Southeast Imports (DSEI)
4/22/2020	83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	2480RXPERSONAL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/26/2012	75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER	118NOT LISTED 341REGISTERED 508NO 510(K)	Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Hangzhou Clongene Biotech Co., Ltd.'s FDA import refusal history?

Hangzhou Clongene Biotech Co., Ltd. (FEI: 3009414546) has 29 FDA import refusal record(s) in our database, spanning from 3/26/2012 to 5/29/2025.

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. Hangzhou Clongene Biotech Co., Ltd.'s FEI number is 3009414546.

What types of violations has Hangzhou Clongene Biotech Co., Ltd. received?

Hangzhou Clongene Biotech Co., Ltd. has been cited for 9 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 Hangzhou Clongene Biotech Co., Ltd. come from?

All FDA import refusal data for Hangzhou Clongene Biotech 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.