Wuhan Huawei Technology Co., Ltd.
⚠️ Moderate Risk
FEI: 3010370474 • Wuhan, Hubei • CHINA
FEI Number
3010370474
Location
Wuhan, Hubei
Country
CHINAAddress
Huazhong International Industrial Park B F 11-3, Yangluo Street; Xinzhou, Wuhan, Hubei, 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
3904
3905
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).
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
STERILITY
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
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 |
|---|---|---|---|
| 7/16/2024 | 79NADDRESSING, WOUND, OCCLUSIVE | Division of Northern Border Imports (DNBI) | |
| 7/16/2024 | 79NADDRESSING, WOUND, OCCLUSIVE | Division of Northern Border Imports (DNBI) | |
| 7/16/2024 | 79NADDRESSING, WOUND, OCCLUSIVE | Division of Northern Border Imports (DNBI) | |
| 7/16/2024 | 79NADDRESSING, WOUND, OCCLUSIVE | Division of Northern Border Imports (DNBI) | |
| 11/30/2017 | 79FRODRESSING, WOUND, DRUG | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 8/13/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Wuhan Huawei Technology Co., Ltd.'s FDA import refusal history?
Wuhan Huawei Technology Co., Ltd. (FEI: 3010370474) has 6 FDA import refusal record(s) in our database, spanning from 8/13/2015 to 7/16/2024.
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. Wuhan Huawei Technology Co., Ltd.'s FEI number is 3010370474.
What types of violations has Wuhan Huawei Technology Co., Ltd. received?
Wuhan Huawei Technology Co., Ltd. has been cited for 8 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 Wuhan Huawei Technology Co., Ltd. come from?
All FDA import refusal data for Wuhan Huawei Technology 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.