HUAGUANG MEDICAL PRODUCTS CO.,LTD.
⚠️ High Risk
FEI: 3015777302 • Jiujiang, Jiangxi • CHINA
FEI Number
3015777302
Location
Jiujiang, Jiangxi
Country
CHINAAddress
Yinsha Wan Industrial Park,High-tech Industrial Zone of Hukou County, , Jiujiang, Jiangxi, 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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).
3905
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.
3904
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/24/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 12/2/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 2/2/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 2/2/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 1/29/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 11/27/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 11/27/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 11/27/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is HUAGUANG MEDICAL PRODUCTS CO.,LTD.'s FDA import refusal history?
HUAGUANG MEDICAL PRODUCTS CO.,LTD. (FEI: 3015777302) has 8 FDA import refusal record(s) in our database, spanning from 11/27/2023 to 4/24/2025.
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. HUAGUANG MEDICAL PRODUCTS CO.,LTD.'s FEI number is 3015777302.
What types of violations has HUAGUANG MEDICAL PRODUCTS CO.,LTD. received?
HUAGUANG MEDICAL PRODUCTS CO.,LTD. has been cited for 7 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 HUAGUANG MEDICAL PRODUCTS CO.,LTD. come from?
All FDA import refusal data for HUAGUANG MEDICAL PRODUCTS 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.