Mildex Technolgy Inc.
⚠️ Moderate Risk
FEI: 3003916259 • Koahsiung • TAIWAN
FEI Number
3003916259
Location
Koahsiung
Country
TAIWANAddress
No. 17 Yong Gong 1str Road, , Yong An Hsiang, Koahsiung, , Taiwan
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/28/2017 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/8/2015 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Los Angeles District Office (LOS-DO) |
| 10/26/2010 | 86HPCSET, LENS, TRIAL, OPHTHALMIC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 9/3/2009 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 5/23/2008 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Mildex Technolgy Inc.'s FDA import refusal history?
Mildex Technolgy Inc. (FEI: 3003916259) has 5 FDA import refusal record(s) in our database, spanning from 5/23/2008 to 7/28/2017.
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. Mildex Technolgy Inc.'s FEI number is 3003916259.
What types of violations has Mildex Technolgy Inc. received?
Mildex Technolgy Inc. 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 Mildex Technolgy Inc. come from?
All FDA import refusal data for Mildex Technolgy Inc. 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.