ZHEJIANG BAOLAI OPTICAL CO LTD
⚠️ Moderate Risk
FEI: 3021564436 • Jinhua, Zhejiang • CHINA
FEI Number
3021564436
Location
Jinhua, Zhejiang
Country
CHINAAddress
Hengfeng Lou 1702, Jiangnan Street Binhong Road; Wucheng, Jinhua, Zhejiang, 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
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 ZHEJIANG BAOLAI OPTICAL CO LTD's FDA import refusal history?
ZHEJIANG BAOLAI OPTICAL CO LTD (FEI: 3021564436) has 2 FDA import refusal record(s) in our database, spanning from 4/28/2025 to 5/30/2025.
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. ZHEJIANG BAOLAI OPTICAL CO LTD's FEI number is 3021564436.
What types of violations has ZHEJIANG BAOLAI OPTICAL CO LTD received?
ZHEJIANG BAOLAI OPTICAL CO LTD has been cited for 2 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 ZHEJIANG BAOLAI OPTICAL CO LTD come from?
All FDA import refusal data for ZHEJIANG BAOLAI OPTICAL 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.