Zhi Hang Soft Rubber Handicrafts Factory
⚠️ Moderate Risk
FEI: 3014694171 • Zhe Jiang • CHINA
FEI Number
3014694171
Location
Zhe Jiang
Country
CHINAAddress
No. 8 Xing Dong Rd, Nian San Li Industrial Zone, Zhe Jiang, , 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).
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.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
Frequently Asked Questions
What is Zhi Hang Soft Rubber Handicrafts Factory's FDA import refusal history?
Zhi Hang Soft Rubber Handicrafts Factory (FEI: 3014694171) has 1 FDA import refusal record(s) in our database, spanning from 11/5/2018 to 11/5/2018.
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. Zhi Hang Soft Rubber Handicrafts Factory's FEI number is 3014694171.
What types of violations has Zhi Hang Soft Rubber Handicrafts Factory received?
Zhi Hang Soft Rubber Handicrafts Factory 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 Zhi Hang Soft Rubber Handicrafts Factory come from?
All FDA import refusal data for Zhi Hang Soft Rubber Handicrafts Factory 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.