GUANGZHOU TECHNICAL CO LLTD
⚠️ Moderate Risk
FEI: 3036535700 • Guangzhou, Guangdong • CHINA
FEI Number
3036535700
Location
Guangzhou, Guangdong
Country
CHINAAddress
6 Lianhua Yan Road, Tianhe District, Guangzhou, Guangdong, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/27/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 5/7/2025 | 83OQW2009 H1N1 INFLUENZA VIRUS (SWINE ORIGIN), NUCLEIC ACID OR ANTIGEN, DETECTION AND IDENTIFICATION | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GUANGZHOU TECHNICAL CO LLTD's FDA import refusal history?
GUANGZHOU TECHNICAL CO LLTD (FEI: 3036535700) has 2 FDA import refusal record(s) in our database, spanning from 5/7/2025 to 5/27/2025.
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 TECHNICAL CO LLTD's FEI number is 3036535700.
What types of violations has GUANGZHOU TECHNICAL CO LLTD received?
GUANGZHOU TECHNICAL CO LLTD has been cited for 4 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 TECHNICAL CO LLTD come from?
All FDA import refusal data for GUANGZHOU TECHNICAL CO LLTD 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.