CLEVERWAVE TECHNOLOGY INC
⚠️ Moderate Risk
FEI: 3006291340 • Taoyuan City, TAOYUAN COUNTY • TAIWAN
FEI Number
3006291340
Location
Taoyuan City, TAOYUAN COUNTY
Country
TAIWANAddress
NO. 30, 1 F, Daren Road, Taoyuan City, TAOYUAN COUNTY, Taiwan
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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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).
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/1/2010 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 333LACKS FIRM | San Francisco District Office (SAN-DO) |
| 3/6/2009 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Seattle District Office (SEA-DO) | |
| 12/11/2008 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 6/17/2008 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 6/17/2008 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 6/17/2008 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is CLEVERWAVE TECHNOLOGY INC's FDA import refusal history?
CLEVERWAVE TECHNOLOGY INC (FEI: 3006291340) has 6 FDA import refusal record(s) in our database, spanning from 6/17/2008 to 3/1/2010.
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. CLEVERWAVE TECHNOLOGY INC's FEI number is 3006291340.
What types of violations has CLEVERWAVE TECHNOLOGY INC received?
CLEVERWAVE TECHNOLOGY INC has been cited for 6 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 CLEVERWAVE TECHNOLOGY INC come from?
All FDA import refusal data for CLEVERWAVE TECHNOLOGY INC 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.