ZHENGZHOU SAICHENG TECHNOLOGY
⚠️ Moderate Risk
FEI: 3016847364 • Zhengzhou • CHINA
FEI Number
3016847364
Location
Zhengzhou
Country
CHINAAddress
No 074 Fl 19 Bldg #5, , Zhengzhou, , 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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/27/2020 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 7/14/2020 | 89OMWADHESIVE BACKED THERMAL SKIN PATCHES | Division of Southeast Imports (DSEI) | |
| 7/14/2020 | 89OMWADHESIVE BACKED THERMAL SKIN PATCHES | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ZHENGZHOU SAICHENG TECHNOLOGY's FDA import refusal history?
ZHENGZHOU SAICHENG TECHNOLOGY (FEI: 3016847364) has 3 FDA import refusal record(s) in our database, spanning from 7/14/2020 to 8/27/2020.
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 SAICHENG TECHNOLOGY's FEI number is 3016847364.
What types of violations has ZHENGZHOU SAICHENG TECHNOLOGY received?
ZHENGZHOU SAICHENG TECHNOLOGY 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 ZHENGZHOU SAICHENG TECHNOLOGY come from?
All FDA import refusal data for ZHENGZHOU SAICHENG TECHNOLOGY 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.