ShenZhen WeiQiQi Technology Co.,Ltd
⚠️ Moderate Risk
FEI: 3014916456 • Shenzhen, Guangdong • CHINA
FEI Number
3014916456
Location
Shenzhen, Guangdong
Country
CHINAAddress
ROOM 306 SUB BUILDING, NO.1, HUANCHENG ROAD OF IN THE TOWN,, Sub Building,No.1,Huancheng Road Of In The Town,Shatoujiao Sub-District,Yantian District, Shenzhen, 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
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.
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).
TPLACKFIRM
This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product manufacturer, packer or distributor.
TPLKUSSLLB
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.
TP VIOL911
This article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product that appears to be in violation of section 911.
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 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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/14/2021 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 12/18/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 10/20/2020 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Division of West Coast Imports (DWCI) | |
| 10/2/2020 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Division of Northern Border Imports (DNBI) | |
| 9/10/2020 | 98LBA01E-CIGARETTE | Division of Southeast Imports (DSEI) | |
| 7/24/2020 | 98LAA02E-CIGARETTE, KIT | Division of Southeast Imports (DSEI) | |
| 6/11/2020 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ShenZhen WeiQiQi Technology Co.,Ltd's FDA import refusal history?
ShenZhen WeiQiQi Technology Co.,Ltd (FEI: 3014916456) has 7 FDA import refusal record(s) in our database, spanning from 6/11/2020 to 6/14/2021.
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. ShenZhen WeiQiQi Technology Co.,Ltd's FEI number is 3014916456.
What types of violations has ShenZhen WeiQiQi Technology Co.,Ltd received?
ShenZhen WeiQiQi Technology Co.,Ltd has been cited for 10 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 ShenZhen WeiQiQi Technology Co.,Ltd come from?
All FDA import refusal data for ShenZhen WeiQiQi Technology 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.