SHENZHEN ENMIND TECHNOLOGY CO LT
⚠️ Moderate Risk
FEI: 3013642239 • Shenzhen, Guangdong • CHINA
FEI Number
3013642239
Location
Shenzhen, Guangdong
Country
CHINAAddress
5th Floor, Block a Defen, Shenzhen, 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
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.
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2023 | 80FRNPUMP, INFUSION | Division of Southeast Imports (DSEI) | |
| 11/22/2023 | 80FRNPUMP, INFUSION | Division of Southeast Imports (DSEI) | |
| 1/15/2021 | 78FIHPUMP, INFUSION OR SYRINGE, EXTRA-LUMINAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/15/2021 | 80FRNPUMP, INFUSION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/24/2018 | 80FRNPUMP, INFUSION | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHENZHEN ENMIND TECHNOLOGY CO LT's FDA import refusal history?
SHENZHEN ENMIND TECHNOLOGY CO LT (FEI: 3013642239) has 5 FDA import refusal record(s) in our database, spanning from 7/24/2018 to 12/11/2023.
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. SHENZHEN ENMIND TECHNOLOGY CO LT's FEI number is 3013642239.
What types of violations has SHENZHEN ENMIND TECHNOLOGY CO LT received?
SHENZHEN ENMIND TECHNOLOGY CO LT 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 SHENZHEN ENMIND TECHNOLOGY CO LT come from?
All FDA import refusal data for SHENZHEN ENMIND TECHNOLOGY CO LT 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.