BRAND ADDITION
⚠️ High Risk
FEI: 3036651372 • Shenshen • CHINA
FEI Number
3036651372
Location
Shenshen
Country
CHINAAddress
3rd Fl, Nb.2 Jinsheng 4th Rd, Shenshen, , China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2025 | 79QAIPOWERED MICRONEEDLE DEVICE | Division of Southeast Imports (DSEI) | |
| 9/18/2025 | 79QQFSKIN MICRONEEDLING MANUAL ROLLER (EXPORT ONLY) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 9/18/2025 | 79QQFSKIN MICRONEEDLING MANUAL ROLLER (EXPORT ONLY) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 9/12/2025 | 79QQFSKIN MICRONEEDLING MANUAL ROLLER (EXPORT ONLY) | Division of Southeast Imports (DSEI) | |
| 6/16/2025 | 80PVZNON-STAINLESS STEEL NEEDLE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BRAND ADDITION's FDA import refusal history?
BRAND ADDITION (FEI: 3036651372) has 5 FDA import refusal record(s) in our database, spanning from 6/16/2025 to 9/24/2025.
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. BRAND ADDITION's FEI number is 3036651372.
What types of violations has BRAND ADDITION received?
BRAND ADDITION 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 BRAND ADDITION come from?
All FDA import refusal data for BRAND ADDITION 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.