SHENZHEN CHANGKUN TEC CO., LTD.
⚠️ Moderate Risk
FEI: 3024614069 • Guangzhou • CHINA
FEI Number
3024614069
Location
Guangzhou
Country
CHINAAddress
801, 3 4 5 6 Floor 7, B Building No 69 Zhenbi Rd, Guangzhou, , 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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/25/2022 | 79PKTLASER FOR DISRUPTION OF ADIPOCYTE CELLS FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 11/25/2022 | 80PWCGENERAL WELLNESS PRODUCT | Division of Southeast Imports (DSEI) | |
| 11/25/2022 | 79PKTLASER FOR DISRUPTION OF ADIPOCYTE CELLS FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 11/25/2022 | 80PWCGENERAL WELLNESS PRODUCT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHENZHEN CHANGKUN TEC CO., LTD.'s FDA import refusal history?
SHENZHEN CHANGKUN TEC CO., LTD. (FEI: 3024614069) has 4 FDA import refusal record(s) in our database, spanning from 11/25/2022 to 11/25/2022.
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 CHANGKUN TEC CO., LTD.'s FEI number is 3024614069.
What types of violations has SHENZHEN CHANGKUN TEC CO., LTD. received?
SHENZHEN CHANGKUN TEC CO., LTD. has been cited for 3 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 CHANGKUN TEC CO., LTD. come from?
All FDA import refusal data for SHENZHEN CHANGKUN TEC 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.