WENZHOU HENGZI GLASSES CO LTD.
✅ Low Risk
FEI: 3013600270 • Wenzhou • CHINA
FEI Number
3013600270
Location
Wenzhou
Country
CHINAAddress
F 5, 49 Nanhui Rd Shanghu, Wenzhou, , 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
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.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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 WENZHOU HENGZI GLASSES CO LTD.'s FDA import refusal history?
WENZHOU HENGZI GLASSES CO LTD. (FEI: 3013600270) has 1 FDA import refusal record(s) in our database, spanning from 8/31/2020 to 8/31/2020.
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. WENZHOU HENGZI GLASSES CO LTD.'s FEI number is 3013600270.
What types of violations has WENZHOU HENGZI GLASSES CO LTD. received?
WENZHOU HENGZI GLASSES 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 WENZHOU HENGZI GLASSES CO LTD. come from?
All FDA import refusal data for WENZHOU HENGZI GLASSES 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.