Dongguan City Risen Medical Products Co., Ltd
⚠️ High Risk
FEI: 3011280379 • Dongguan, Guangdong • CHINA
FEI Number
3011280379
Location
Dongguan, Guangdong
Country
CHINAAddress
No. 7 Chuangye Industrial Park, Jianshazhou, , 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
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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).
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.
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.
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).
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
STERILITY
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
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.
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2024 | 80OKIEMERGENCY RESPONSE SAFETY KIT | 304STERILITY | Division of West Coast Imports (DWCI) |
| 10/9/2024 | 79OHOFIRST AID KIT WITHOUT DRUG | 78STERILITY | Division of West Coast Imports (DWCI) |
| 2/9/2022 | 79OHOFIRST AID KIT WITHOUT DRUG | 78STERILITY | Division of West Coast Imports (DWCI) |
| 2/9/2022 | 79OHOFIRST AID KIT WITHOUT DRUG | 78STERILITY | Division of West Coast Imports (DWCI) |
| 6/12/2021 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of West Coast Imports (DWCI) | |
| 10/5/2020 | 73CBPVALVE, NON-REBREATHING | Division of West Coast Imports (DWCI) | |
| 8/29/2020 | 79KGXTAPE AND BANDAGE, ADHESIVE | 78STERILITY | Division of Southeast Imports (DSEI) |
| 2/18/2020 | 79OHOFIRST AID KIT WITHOUT DRUG | 78STERILITY | Division of Northeast Imports (DNEI) |
| 1/15/2020 | 80FQMBANDAGE, ELASTIC | Division of Southwest Imports (DSWI) | |
| 1/15/2020 | 79EFQSPONGE, GAUZE | Division of Southwest Imports (DSWI) | |
| 1/15/2020 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Southwest Imports (DSWI) | |
| 11/18/2019 | 80OVRKIT, FIRST AID, TALKING | Division of Southeast Imports (DSEI) | |
| 9/5/2019 | 79OHOFIRST AID KIT WITHOUT DRUG | 78STERILITY | Division of Southeast Imports (DSEI) |
| 7/23/2019 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of Southeast Imports (DSEI) | |
| 7/12/2019 | 79OHOFIRST AID KIT WITHOUT DRUG | 78STERILITY | Division of Northern Border Imports (DNBI) |
| 6/19/2019 | 79OHOFIRST AID KIT WITHOUT DRUG | 78STERILITY | Division of West Coast Imports (DWCI) |
| 6/19/2019 | 79OHOFIRST AID KIT WITHOUT DRUG | 78STERILITY | Division of West Coast Imports (DWCI) |
| 5/28/2019 | 79OHOFIRST AID KIT WITHOUT DRUG | 78STERILITY | Division of West Coast Imports (DWCI) |
| 12/19/2018 | 79OHOFIRST AID KIT WITHOUT DRUG | 2800POSS N/STR | Division of Northern Border Imports (DNBI) |
| 12/19/2018 | 79OHOFIRST AID KIT WITHOUT DRUG | 78STERILITY | Division of Northern Border Imports (DNBI) |
| 7/20/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/22/2017 | 79LRRKIT, FIRST AID | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 5/22/2017 | 73CBKVENTILATOR, CONTINUOUS (RESPIRATOR) | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 7/6/2016 | 79OHOFIRST AID KIT WITHOUT DRUG | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Dongguan City Risen Medical Products Co., Ltd's FDA import refusal history?
Dongguan City Risen Medical Products Co., Ltd (FEI: 3011280379) has 24 FDA import refusal record(s) in our database, spanning from 7/6/2016 to 10/24/2024.
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. Dongguan City Risen Medical Products Co., Ltd's FEI number is 3011280379.
What types of violations has Dongguan City Risen Medical Products Co., Ltd received?
Dongguan City Risen Medical Products Co., Ltd has been cited for 9 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 City Risen Medical Products Co., Ltd come from?
All FDA import refusal data for Dongguan City Risen 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.