GUANGZHOU AIYINMEI CO LTD
⚠️ High Risk
FEI: 3016744846 • Guangzhou, Guangdong • CHINA
FEI Number
3016744846
Location
Guangzhou, Guangdong
Country
CHINAAddress
Tieshanhe Road, F/2; No. 18-21 San Dong Avenue; Xinhuazhen Huadou, Guangzhou, Guangdong, 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 10/23/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of West Coast Imports (DWCI) | |
| 7/31/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 7/22/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 7/9/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northeast Imports (DNEI) |
| 6/29/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/29/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/29/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 80ORWN95 RESPIRATOR WITH ANTIMICROBIAL/ANTIVIRAL AGENT FOR USE BY THE GENERAL PUBLIC IN PUBLIC HEALTH MED | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/17/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is GUANGZHOU AIYINMEI CO LTD's FDA import refusal history?
GUANGZHOU AIYINMEI CO LTD (FEI: 3016744846) has 11 FDA import refusal record(s) in our database, spanning from 6/17/2020 to 10/23/2020.
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. GUANGZHOU AIYINMEI CO LTD's FEI number is 3016744846.
What types of violations has GUANGZHOU AIYINMEI CO LTD received?
GUANGZHOU AIYINMEI CO LTD 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 GUANGZHOU AIYINMEI CO LTD come from?
All FDA import refusal data for GUANGZHOU AIYINMEI CO LTD 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.