ORGANIC MINH ANH COSMETIC MEDICINE COMPANY LIMITED
⚠️ Moderate Risk
FEI: 3016790013 • Buu Cuc Trung Tam Thanh Pho Ho Chi Minh, Ho Chi Minh • VIETNAM
FEI Number
3016790013
Location
Buu Cuc Trung Tam Thanh Pho Ho Chi Minh, Ho Chi Minh
Country
VIETNAMAddress
No. 44-46, Tran Hung Dao Street, , Buu Cuc Trung Tam Thanh Pho Ho Chi Minh, Ho Chi Minh, Vietnam
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
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 |
|---|---|---|---|
| 1/22/2021 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ORGANIC MINH ANH COSMETIC MEDICINE COMPANY LIMITED's FDA import refusal history?
ORGANIC MINH ANH COSMETIC MEDICINE COMPANY LIMITED (FEI: 3016790013) has 1 FDA import refusal record(s) in our database, spanning from 1/22/2021 to 1/22/2021.
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. ORGANIC MINH ANH COSMETIC MEDICINE COMPANY LIMITED's FEI number is 3016790013.
What types of violations has ORGANIC MINH ANH COSMETIC MEDICINE COMPANY LIMITED received?
ORGANIC MINH ANH COSMETIC MEDICINE COMPANY LIMITED has been cited for 1 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 ORGANIC MINH ANH COSMETIC MEDICINE COMPANY LIMITED come from?
All FDA import refusal data for ORGANIC MINH ANH COSMETIC MEDICINE COMPANY 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.