GORTECH INDUSTRIES CO LTD
⚠️ Moderate Risk
FEI: 3012219803 • Huizhou • CHINA
FEI Number
3012219803
Location
Huizhou
Country
CHINAAddress
Wan LI, Industrial Zone, Huizhou, , 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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2023 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | Division of West Coast Imports (DWCI) |
| 9/16/2016 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Seattle District Office (SEA-DO) |
| 9/16/2016 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Seattle District Office (SEA-DO) |
| 9/16/2016 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Seattle District Office (SEA-DO) |
| 9/16/2016 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is GORTECH INDUSTRIES CO LTD's FDA import refusal history?
GORTECH INDUSTRIES CO LTD (FEI: 3012219803) has 5 FDA import refusal record(s) in our database, spanning from 9/16/2016 to 8/2/2023.
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. GORTECH INDUSTRIES CO LTD's FEI number is 3012219803.
What types of violations has GORTECH INDUSTRIES CO LTD received?
GORTECH INDUSTRIES CO LTD has been cited for 2 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 GORTECH INDUSTRIES CO LTD come from?
All FDA import refusal data for GORTECH INDUSTRIES 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.