THEP SHOP
✅ Low Risk
FEI: 3016516623 • Bangkok • THAILAND
FEI Number
3016516623
Location
Bangkok
Country
THAILANDAddress
120 380 Wutthi Phan Alley, , Bangkok, , Thailand
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.
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 THEP SHOP's FDA import refusal history?
THEP SHOP (FEI: 3016516623) has 1 FDA import refusal record(s) in our database, spanning from 3/24/2020 to 3/24/2020.
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. THEP SHOP's FEI number is 3016516623.
What types of violations has THEP SHOP received?
THEP SHOP 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 THEP SHOP come from?
All FDA import refusal data for THEP SHOP 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.