Wuhan Huahai Century Laser Co. Ltd.
⚠️ Moderate Risk
FEI: 3009597048 • Wuhan, Hubei • CHINA
FEI Number
3009597048
Location
Wuhan, Hubei
Country
CHINAAddress
FUHUSHAN INDUSTRY PARK. NO 87, ZHUODAOQUAN ROAD, HONGSHAN DISTRICT, Wuhan, Hubei, 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 TAG
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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/24/2022 | 95RHKLASER MARKER OR ENGRAVER | Division of West Coast Imports (DWCI) | |
| 3/17/2020 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Division of West Coast Imports (DWCI) | |
| 10/1/2019 | 95RHKLASER MARKER OR ENGRAVER | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Wuhan Huahai Century Laser Co. Ltd.'s FDA import refusal history?
Wuhan Huahai Century Laser Co. Ltd. (FEI: 3009597048) has 3 FDA import refusal record(s) in our database, spanning from 10/1/2019 to 3/24/2022.
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. Wuhan Huahai Century Laser Co. Ltd.'s FEI number is 3009597048.
What types of violations has Wuhan Huahai Century Laser Co. Ltd. received?
Wuhan Huahai Century Laser Co. Ltd. has been cited for 3 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 Wuhan Huahai Century Laser Co. Ltd. come from?
All FDA import refusal data for Wuhan Huahai Century Laser 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.