Aid United International Co. Limited
⚠️ Moderate Risk
FEI: 3006451935 • Shanghai • CHINA
FEI Number
3006451935
Location
Shanghai
Country
CHINAAddress
1065 Wuzhong Road, , Shanghai, , 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/12/2021 | 89ILHSPLINT, HAND, AND COMPONENTS | Division of West Coast Imports (DWCI) | |
| 1/17/2018 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 1/17/2018 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 1/17/2018 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 1/17/2018 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 1/17/2018 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 1/17/2018 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 1/17/2018 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 1/17/2018 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 1/17/2018 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 2/22/2011 | 80FRLFIBER, MEDICAL, ABSORBENT | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Aid United International Co. Limited's FDA import refusal history?
Aid United International Co. Limited (FEI: 3006451935) has 11 FDA import refusal record(s) in our database, spanning from 2/22/2011 to 10/12/2021.
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. Aid United International Co. Limited's FEI number is 3006451935.
What types of violations has Aid United International Co. Limited received?
Aid United International Co. Limited 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 Aid United International Co. Limited come from?
All FDA import refusal data for Aid United International Co. 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.