SHENZHEN INTERMED
⚠️ Moderate Risk
FEI: 3012982269 • SHENZHEN • CHINA
FEI Number
3012982269
Location
SHENZHEN
Country
CHINAAddress
64 MAJIALONG INDUSTRY Z, , SHENZHEN, , 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 |
|---|---|---|---|
| 5/22/2019 | 91DJZDEVICES, BREATH TRAPPING, ALCOHOL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/22/2019 | 91DJZDEVICES, BREATH TRAPPING, ALCOHOL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/18/2017 | 91DJZDEVICES, BREATH TRAPPING, ALCOHOL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/18/2017 | 91DJZDEVICES, BREATH TRAPPING, ALCOHOL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHENZHEN INTERMED's FDA import refusal history?
SHENZHEN INTERMED (FEI: 3012982269) has 4 FDA import refusal record(s) in our database, spanning from 1/18/2017 to 5/22/2019.
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 INTERMED's FEI number is 3012982269.
What types of violations has SHENZHEN INTERMED received?
SHENZHEN INTERMED 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 SHENZHEN INTERMED come from?
All FDA import refusal data for SHENZHEN INTERMED 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.