JIUZHOUHANG HUOYUNDAI CO LAD
✅ Low Risk
FEI: 3013643698 • Guangzhou, Guangdong • CHINA
FEI Number
3013643698
Location
Guangzhou, Guangdong
Country
CHINAAddress
Hengan Road, No 2 Xiao North Rd; Yuexiu District, Guangzhou, Guangdong, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
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.
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).
Refusal History
Frequently Asked Questions
What is JIUZHOUHANG HUOYUNDAI CO LAD's FDA import refusal history?
JIUZHOUHANG HUOYUNDAI CO LAD (FEI: 3013643698) has 1 FDA import refusal record(s) in our database, spanning from 10/27/2017 to 10/27/2017.
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. JIUZHOUHANG HUOYUNDAI CO LAD's FEI number is 3013643698.
What types of violations has JIUZHOUHANG HUOYUNDAI CO LAD received?
JIUZHOUHANG HUOYUNDAI CO LAD 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 JIUZHOUHANG HUOYUNDAI CO LAD come from?
All FDA import refusal data for JIUZHOUHANG HUOYUNDAI CO LAD 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.