Shenzhen Atc Network Scienology
⚠️ Moderate Risk
FEI: 3009931530 • Baoan • 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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 12/15/2015 | 77OSMHEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY | Division of Northern Border Imports (DNBI) | |
| 12/15/2015 | 77OSMHEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY | Division of Northern Border Imports (DNBI) | |
| 8/12/2014 | 77OSMHEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY | Division of Northern Border Imports (DNBI) | |
| 7/18/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Shenzhen Atc Network Scienology's FDA import refusal history?
Shenzhen Atc Network Scienology (FEI: 3009931530) has 4 FDA import refusal record(s) in our database, spanning from 7/18/2013 to 12/15/2015.
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 Atc Network Scienology's FEI number is 3009931530.
What types of violations has Shenzhen Atc Network Scienology received?
Shenzhen Atc Network Scienology has been cited for 6 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 Atc Network Scienology come from?
All FDA import refusal data for Shenzhen Atc Network Scienology 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.