Top Respect Industrial (Shenzhen) Limited
⚠️ Moderate Risk
FEI: 3006810442 • Shenzhen, Guangdong • CHINA
FEI Number
3006810442
Location
Shenzhen, Guangdong
Country
CHINAAddress
Ind. Da, Tianxiacun, 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/7/2008 | 76EASGEL, ELECTRODE, FOR PULP TESTER | Los Angeles District Office (LOS-DO) | |
| 8/7/2008 | 79OBSLIGHT EMITTING SYSTEM, LOW LEVEL, BIOSTIMULATION | Los Angeles District Office (LOS-DO) | |
| 8/7/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/7/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/7/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Top Respect Industrial (Shenzhen) Limited's FDA import refusal history?
Top Respect Industrial (Shenzhen) Limited (FEI: 3006810442) has 5 FDA import refusal record(s) in our database, spanning from 8/7/2008 to 8/7/2008.
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. Top Respect Industrial (Shenzhen) Limited's FEI number is 3006810442.
What types of violations has Top Respect Industrial (Shenzhen) Limited received?
Top Respect Industrial (Shenzhen) Limited has been cited for 2 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 Top Respect Industrial (Shenzhen) Limited come from?
All FDA import refusal data for Top Respect Industrial (Shenzhen) Limited 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.