Shenzhen Tiande Electron Co., Ltd.
⚠️ Moderate Risk
FEI: 3008492080 • Buji Town • CHINA
FEI Number
3008492080
Location
Buji Town
Country
CHINAAddress
Block 2, 2 Xiacun Industry; Shenzhen Longgang Dist., Buji Town, , 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
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.
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
Frequently Asked Questions
What is Shenzhen Tiande Electron Co., Ltd.'s FDA import refusal history?
Shenzhen Tiande Electron Co., Ltd. (FEI: 3008492080) has 2 FDA import refusal record(s) in our database, spanning from 11/30/2011 to 12/5/2011.
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 Tiande Electron Co., Ltd.'s FEI number is 3008492080.
What types of violations has Shenzhen Tiande Electron Co., Ltd. received?
Shenzhen Tiande Electron 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 Shenzhen Tiande Electron Co., Ltd. come from?
All FDA import refusal data for Shenzhen Tiande Electron 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.