Zhengzhou PZ Laser Slim Technology Co., Ltd.
⚠️ Moderate Risk
FEI: 3013613043 • Zhengzhou, Henan • CHINA
FEI Number
3013613043
Location
Zhengzhou, Henan
Country
CHINAAddress
3rd Floor, Building 1, No. 101 Jinbai Road, High-tech Development Zone, Zhengzhou, Henan, 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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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
Frequently Asked Questions
What is Zhengzhou PZ Laser Slim Technology Co., Ltd.'s FDA import refusal history?
Zhengzhou PZ Laser Slim Technology Co., Ltd. (FEI: 3013613043) has 2 FDA import refusal record(s) in our database, spanning from 7/27/2017 to 1/25/2018.
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. Zhengzhou PZ Laser Slim Technology Co., Ltd.'s FEI number is 3013613043.
What types of violations has Zhengzhou PZ Laser Slim Technology Co., Ltd. received?
Zhengzhou PZ Laser Slim Technology Co., Ltd. has been cited for 7 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 Zhengzhou PZ Laser Slim Technology Co., Ltd. come from?
All FDA import refusal data for Zhengzhou PZ Laser Slim Technology 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.