Kun Ming Dewei Optical Instrument Co, Ltd.
⚠️ Moderate Risk
FEI: 3007517041 • Kunming, Ynnn • CHINA
FEI Number
3007517041
Location
Kunming, Ynnn
Country
CHINAAddress
12 Nanmenjie; #2 GROUP XINKETING, HUILONG CUN, Kungyang Town, Kunming, Ynnn, 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
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.
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.
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.
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.
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 |
|---|---|---|---|
| 10/12/2018 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Southwest Imports (DSWI) |
| 10/12/2018 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Southwest Imports (DSWI) |
| 11/15/2017 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Southwest Imports (DSWI) |
| 11/13/2017 | 95RETLASER TARGET DESIGNATOR, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Northeast Imports (DNEI) |
| 11/13/2017 | 95RETLASER TARGET DESIGNATOR, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Northeast Imports (DNEI) |
| 10/11/2017 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Southwest Imports (DSWI) |
| 10/11/2017 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Southwest Imports (DSWI) |
| 8/7/2017 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Division of Southwest Imports (DSWI) | |
| 4/29/2011 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Southwest Import District Office (SWI-DO) | |
| 3/9/2011 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 3/9/2011 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 11/12/2010 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 10/5/2010 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Kun Ming Dewei Optical Instrument Co, Ltd.'s FDA import refusal history?
Kun Ming Dewei Optical Instrument Co, Ltd. (FEI: 3007517041) has 13 FDA import refusal record(s) in our database, spanning from 10/5/2010 to 10/12/2018.
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. Kun Ming Dewei Optical Instrument Co, Ltd.'s FEI number is 3007517041.
What types of violations has Kun Ming Dewei Optical Instrument Co, Ltd. received?
Kun Ming Dewei Optical Instrument Co, Ltd. 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 Kun Ming Dewei Optical Instrument Co, Ltd. come from?
All FDA import refusal data for Kun Ming Dewei Optical Instrument 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.