BRAND ADDITION LTD ASIAPACK
⚠️ Moderate Risk
FEI: 3038134610 • Shenzhen, Guangdong • CHINA
FEI Number
3038134610
Location
Shenzhen, Guangdong
Country
CHINAAddress
Nb2 Jinsheng 4thrd 3rd Fl, Lanzhu Road; Pingshanjie Dao Longgang Districtnorthside, 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).
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.
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 |
|---|---|---|---|
| 9/2/2025 | 79QQFSKIN MICRONEEDLING MANUAL ROLLER (EXPORT ONLY) | Division of Southeast Imports (DSEI) | |
| 8/22/2025 | 79QQFSKIN MICRONEEDLING MANUAL ROLLER (EXPORT ONLY) | Division of Northeast Imports (DNEI) | |
| 8/8/2025 | 79QQFSKIN MICRONEEDLING MANUAL ROLLER (EXPORT ONLY) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BRAND ADDITION LTD ASIAPACK's FDA import refusal history?
BRAND ADDITION LTD ASIAPACK (FEI: 3038134610) has 3 FDA import refusal record(s) in our database, spanning from 8/8/2025 to 9/2/2025.
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 LTD ASIAPACK's FEI number is 3038134610.
What types of violations has BRAND ADDITION LTD ASIAPACK received?
BRAND ADDITION LTD ASIAPACK 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 LTD ASIAPACK come from?
All FDA import refusal data for BRAND ADDITION LTD ASIAPACK 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.