MEDSINGLONG CO LTD
⚠️ Moderate Risk
FEI: 3016860442 • Guangzhou, Guangdong • CHINA
FEI Number
3016860442
Location
Guangzhou, Guangdong
Country
CHINAAddress
W Fuhua Rd, Rm 405, S C Floor 1st, 4th,5th, No 85th, 89th,Baiyun Road, Shiqiao Street, Panyu District; Fanyu District, Guangzhou, Guangdong, 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
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.
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).
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.
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).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2023 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/12/2021 | 74OCHOXIMETER, INFRARED, SPORTING, AVIATION | Division of Southeast Imports (DSEI) | |
| 3/5/2021 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 10/9/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/14/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Northern Border Imports (DNBI) | |
| 5/11/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is MEDSINGLONG CO LTD's FDA import refusal history?
MEDSINGLONG CO LTD (FEI: 3016860442) has 6 FDA import refusal record(s) in our database, spanning from 5/11/2020 to 4/10/2023.
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. MEDSINGLONG CO LTD's FEI number is 3016860442.
What types of violations has MEDSINGLONG CO LTD received?
MEDSINGLONG CO LTD has been cited for 6 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 MEDSINGLONG CO LTD come from?
All FDA import refusal data for MEDSINGLONG 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.