Guangzhou Wondfo Biotech Co., Ltd.
⚠️ High Risk
FEI: 3004635103 • Guangzhou, Guangdong • CHINA
FEI Number
3004635103
Location
Guangzhou, Guangdong
Country
CHINAAddress
501 Rom, 5f Self-Edited Building 1, No. 8 Lizhishan Road; Huangpu District Science City, Guangzhou, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
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.
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).
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.
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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/6/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 5/9/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/24/2022 | 83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/30/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 2380NO PMA/PDP | Division of Northern Border Imports (DNBI) |
| 7/8/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 6/5/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 5/26/2020 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 5/26/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 5/13/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/12/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/6/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 4/29/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 4/29/2020 | 83OTGNON-SARS CORONAVIRUS MULTIPLEX NUCLEIC ACID ASSAY | Division of Southeast Imports (DSEI) | |
| 4/29/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 4/24/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 4/23/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 4/14/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 5/18/2017 | 91LDJENZYME IMMUNOASSAY, CANNABINOIDS | Division of Southeast Imports (DSEI) | |
| 9/28/2011 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Guangzhou Wondfo Biotech Co., Ltd.'s FDA import refusal history?
Guangzhou Wondfo Biotech Co., Ltd. (FEI: 3004635103) has 19 FDA import refusal record(s) in our database, spanning from 9/28/2011 to 5/6/2025.
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. Guangzhou Wondfo Biotech Co., Ltd.'s FEI number is 3004635103.
What types of violations has Guangzhou Wondfo Biotech Co., Ltd. received?
Guangzhou Wondfo 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 Guangzhou Wondfo Biotech Co., Ltd. come from?
All FDA import refusal data for Guangzhou Wondfo 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.