Shanghai Kindmax Sports Products Co.,Ltd
⚠️ Moderate Risk
FEI: 3008763123 • Shanghai, Shanghai • CHINA
FEI Number
3008763123
Location
Shanghai, Shanghai
Country
CHINAAddress
Floor 3, No. 516 Wenchuan Road, Baoshan District, Shanghai, Shanghai, 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
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/6/2021 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Southeast Imports (DSEI) | |
| 5/1/2020 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Southeast Imports (DSEI) | |
| 7/31/2017 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/10/2017 | 79LRRKIT, FIRST AID | Division of Northern Border Imports (DNBI) | |
| 9/29/2015 | 80FQMBANDAGE, ELASTIC | Southwest Import District Office (SWI-DO) | |
| 9/23/2014 | 80FQMBANDAGE, ELASTIC | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shanghai Kindmax Sports Products Co.,Ltd's FDA import refusal history?
Shanghai Kindmax Sports Products Co.,Ltd (FEI: 3008763123) has 6 FDA import refusal record(s) in our database, spanning from 9/23/2014 to 7/6/2021.
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. Shanghai Kindmax Sports Products Co.,Ltd's FEI number is 3008763123.
What types of violations has Shanghai Kindmax Sports Products Co.,Ltd received?
Shanghai Kindmax Sports Products Co.,Ltd has been cited for 4 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 Shanghai Kindmax Sports Products Co.,Ltd come from?
All FDA import refusal data for Shanghai Kindmax Sports 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.