GUANGZHOU SHIYI TECHNOLOGY CO.,
⚠️ High Risk
FEI: 3017470808 • Guangzhou • 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
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 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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/11/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 6/3/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 5/28/2025 | 75PHGDROPLET DIGITAL PCR SYSTEM | Division of Southeast Imports (DSEI) | |
| 5/28/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 5/28/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 5/28/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/19/2025 | 82OCBRT-PCR MULTIGENE EXPRESSION TEST, SENTINEL LYMPH NODE, CANCER METASTASIS DETECTION | Division of Southeast Imports (DSEI) | |
| 5/9/2025 | 83MIZENZYME LINKED IMMUNOABSORBENT ASSAY, HISTOPLASMA CAPSULATUM | Division of Southeast Imports (DSEI) | |
| 5/9/2025 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 5/7/2025 | 83QWBOVER-THE-COUNTER MOLECULAR TEST TO DETECT SARS-COV-2 | Division of Southeast Imports (DSEI) | |
| 5/7/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 5/5/2025 | 75OLDINTERNAL POLYMERASE CHAIN REACTION CONTROL, NOT ASSAY SPECIFIC | Division of Southeast Imports (DSEI) | |
| 5/5/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 5/2/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 5/2/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 5/2/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 5/2/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 5/2/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 4/29/2025 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 4/29/2025 | 82OYVINHERITED NUCLEOTIDE REPEAT DISORDER DNA TEST | Division of Southeast Imports (DSEI) | |
| 4/29/2025 | 82OCBRT-PCR MULTIGENE EXPRESSION TEST, SENTINEL LYMPH NODE, CANCER METASTASIS DETECTION | Division of Southeast Imports (DSEI) | |
| 4/29/2025 | 88LNJANALYZER, CHROMOSOME, AUTOMATED | Division of Southeast Imports (DSEI) | |
| 4/18/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 4/18/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 4/14/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 4/3/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 4/1/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GUANGZHOU SHIYI TECHNOLOGY CO.,'s FDA import refusal history?
GUANGZHOU SHIYI TECHNOLOGY CO., (FEI: 3017470808) has 27 FDA import refusal record(s) in our database, spanning from 4/1/2025 to 6/11/2025.
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 SHIYI TECHNOLOGY CO.,'s FEI number is 3017470808.
What types of violations has GUANGZHOU SHIYI TECHNOLOGY CO., received?
GUANGZHOU SHIYI TECHNOLOGY CO., has been cited for 5 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 SHIYI TECHNOLOGY CO., come from?
All FDA import refusal data for GUANGZHOU SHIYI TECHNOLOGY CO., 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.