Shenzhen Sky Dragon Audio Video Technology Co., Ltd.
⚠️ Moderate Risk
FEI: 3009846950 • Shenzhen, Guangdong • CHINA
FEI Number
3009846950
Location
Shenzhen, Guangdong
Country
CHINAAddress
Factory Bldg 1, 03 Left, 04 Layer Right; Baoan 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
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).
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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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 |
|---|---|---|---|
| 1/27/2020 | 76EFSUNIT, ORAL IRRIGATION | Division of Southeast Imports (DSEI) | |
| 12/9/2019 | 89KNMDEVICE, PRESSURE APPLYING | Division of Northern Border Imports (DNBI) | |
| 3/26/2018 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Shenzhen Sky Dragon Audio Video Technology Co., Ltd.'s FDA import refusal history?
Shenzhen Sky Dragon Audio Video Technology Co., Ltd. (FEI: 3009846950) has 3 FDA import refusal record(s) in our database, spanning from 3/26/2018 to 1/27/2020.
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 Sky Dragon Audio Video Technology Co., Ltd.'s FEI number is 3009846950.
What types of violations has Shenzhen Sky Dragon Audio Video Technology Co., Ltd. received?
Shenzhen Sky Dragon Audio Video Technology Co., Ltd. has been cited for 4 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 Sky Dragon Audio Video Technology Co., Ltd. come from?
All FDA import refusal data for Shenzhen Sky Dragon Audio Video 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.