SOLARLENS CO LTD
⚠️ Moderate Risk
FEI: 3012356976 • Phra Nakhon Si Ayutthaya, Phra Nakhon Si Ayutthaya • THAILAND
FEI Number
3012356976
Location
Phra Nakhon Si Ayutthaya, Phra Nakhon Si Ayutthaya
Country
THAILANDAddress
2999 Bangpa-in Industri, , Phra Nakhon Si Ayutthaya, Phra Nakhon Si Ayutthaya, Thailand
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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.
Refusal History
Frequently Asked Questions
What is SOLARLENS CO LTD's FDA import refusal history?
SOLARLENS CO LTD (FEI: 3012356976) has 1 FDA import refusal record(s) in our database, spanning from 2/15/2018 to 2/15/2018.
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. SOLARLENS CO LTD's FEI number is 3012356976.
What types of violations has SOLARLENS CO LTD received?
SOLARLENS 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 SOLARLENS CO LTD come from?
All FDA import refusal data for SOLARLENS 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.