Tronform Industries Ltd.
⚠️ Moderate Risk
FEI: 1000211176 • Tsuen Wan, New Territories • HONG KONG
FEI Number
1000211176
Location
Tsuen Wan, New Territories
Country
HONG KONGAddress
Flat K, 9/F, Houston Industrial Bldg.; 32-40 Wang Lung Street, Tsuen Wan, New Territories, Hong Kong
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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/5/2012 | 86HOISPECTACLE, MAGNIFYING | Seattle District Office (SEA-DO) | |
| 9/5/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Seattle District Office (SEA-DO) | |
| 9/5/2012 | 86HOISPECTACLE, MAGNIFYING | Seattle District Office (SEA-DO) | |
| 9/5/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Seattle District Office (SEA-DO) | |
| 9/5/2012 | 86HOISPECTACLE, MAGNIFYING | Seattle District Office (SEA-DO) | |
| 9/5/2012 | 86HOISPECTACLE, MAGNIFYING | Seattle District Office (SEA-DO) | |
| 5/30/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Tronform Industries Ltd.'s FDA import refusal history?
Tronform Industries Ltd. (FEI: 1000211176) has 7 FDA import refusal record(s) in our database, spanning from 5/30/2012 to 9/5/2012.
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. Tronform Industries Ltd.'s FEI number is 1000211176.
What types of violations has Tronform Industries Ltd. received?
Tronform Industries 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 Tronform Industries Ltd. come from?
All FDA import refusal data for Tronform Industries 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.