Qingdao London Durex Co., Ltd.
⚠️ High Risk
FEI: 3008559248 • Qingdao, Shandong • CHINA
FEI Number
3008559248
Location
Qingdao, Shandong
Country
CHINAAddress
No. 1-13 Shangma Part, Aodong Road, Chengyang, Qingdao, Shandong, 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.
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.
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.
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.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
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
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/14/2025 | 85HISCONDOM | Division of West Coast Imports (DWCI) | |
| 5/13/2025 | 85HISCONDOM | Division of West Coast Imports (DWCI) | |
| 5/13/2025 | 85HISCONDOM | Division of West Coast Imports (DWCI) | |
| 5/13/2025 | 85HISCONDOM | Division of West Coast Imports (DWCI) | |
| 5/13/2025 | 85HISCONDOM | Division of West Coast Imports (DWCI) | |
| 4/10/2025 | 85HISCONDOM | 477HOLES | Division of West Coast Imports (DWCI) |
| 4/10/2025 | 85HISCONDOM | 477HOLES | Division of West Coast Imports (DWCI) |
| 4/10/2025 | 85HISCONDOM | 477HOLES | Division of West Coast Imports (DWCI) |
| 4/10/2025 | 85HISCONDOM | 477HOLES | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Qingdao London Durex Co., Ltd.'s FDA import refusal history?
Qingdao London Durex Co., Ltd. (FEI: 3008559248) has 9 FDA import refusal record(s) in our database, spanning from 4/10/2025 to 5/14/2025.
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. Qingdao London Durex Co., Ltd.'s FEI number is 3008559248.
What types of violations has Qingdao London Durex Co., Ltd. received?
Qingdao London Durex 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 Qingdao London Durex Co., Ltd. come from?
All FDA import refusal data for Qingdao London Durex 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.