DONGGUAN HUAGANG COMMUNICATION TECHNOLOGY CO., LTD.
⚠️ High Risk
FEI: 3016630989 • Dongguan, Guangdong • CHINA
FEI Number
3016630989
Location
Dongguan, Guangdong
Country
CHINAAddress
Jinhe Road, No 78 Changping Jinmeicun; Changping Town, Dongguan, 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 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.
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).
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).
NIOSH-EUA
The respirator is from a lot or shipment that failed testing and, pursuant to a condition of the applicable emergency use authorization (EUA), cannot be distributed.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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 |
|---|---|---|---|
| 3/26/2021 | 80FXXMASK, SURGICAL | Division of Northern Border Imports (DNBI) | |
| 3/26/2021 | 80FXXMASK, SURGICAL | Division of Northern Border Imports (DNBI) | |
| 3/26/2021 | 80FXXMASK, SURGICAL | Division of Northern Border Imports (DNBI) | |
| 3/26/2021 | 80FXXMASK, SURGICAL | Division of Northern Border Imports (DNBI) | |
| 3/26/2021 | 80FXXMASK, SURGICAL | Division of Northern Border Imports (DNBI) | |
| 10/9/2020 | 80LYUACCESSORY, SURGICAL APPAREL | Division of Southwest Imports (DSWI) | |
| 10/2/2020 | 80FXXMASK, SURGICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 9/28/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | Division of Southeast Imports (DSEI) | |
| 8/27/2020 | 80LYUACCESSORY, SURGICAL APPAREL | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 8/26/2020 | 80QKUNON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) | Division of West Coast Imports (DWCI) | |
| 8/17/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 8/17/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 8/10/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 8/3/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 7/21/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 7/2/2020 | 80LYUACCESSORY, SURGICAL APPAREL | Division of Southeast Imports (DSEI) | |
| 6/23/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/5/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DONGGUAN HUAGANG COMMUNICATION TECHNOLOGY CO., LTD.'s FDA import refusal history?
DONGGUAN HUAGANG COMMUNICATION TECHNOLOGY CO., LTD. (FEI: 3016630989) has 19 FDA import refusal record(s) in our database, spanning from 6/5/2020 to 3/26/2021.
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. DONGGUAN HUAGANG COMMUNICATION TECHNOLOGY CO., LTD.'s FEI number is 3016630989.
What types of violations has DONGGUAN HUAGANG COMMUNICATION TECHNOLOGY CO., LTD. received?
DONGGUAN HUAGANG COMMUNICATION TECHNOLOGY 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 DONGGUAN HUAGANG COMMUNICATION TECHNOLOGY CO., LTD. come from?
All FDA import refusal data for DONGGUAN HUAGANG COMMUNICATION 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.