Shenzhen Ottimo Eyewear Optical Co., Ltd.
⚠️ Moderate Risk
FEI: 3005632180 • Shenzhen • CHINA
FEI Number
3005632180
Location
Shenzhen
Country
CHINAAddress
No. 4, No 3 Road, Baolong Badao,, Baolong Industrial Zone, Longgang Distri, Shenzhen, , 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 IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
Frequently Asked Questions
What is Shenzhen Ottimo Eyewear Optical Co., Ltd.'s FDA import refusal history?
Shenzhen Ottimo Eyewear Optical Co., Ltd. (FEI: 3005632180) has 1 FDA import refusal record(s) in our database, spanning from 6/20/2016 to 6/20/2016.
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. Shenzhen Ottimo Eyewear Optical Co., Ltd.'s FEI number is 3005632180.
What types of violations has Shenzhen Ottimo Eyewear Optical Co., Ltd. received?
Shenzhen Ottimo Eyewear 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 Shenzhen Ottimo Eyewear Optical Co., Ltd. come from?
All FDA import refusal data for Shenzhen Ottimo Eyewear 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.