Opti-Magician Technology Inc.
⚠️ Moderate Risk
FEI: 3001650549 • Taipei • TAIWAN
FEI Number
3001650549
Location
Taipei
Country
TAIWANAddress
No. 2 Lane, 88 Kwang Fu Road Sec.2, Sang, Taipei, , 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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
Frequently Asked Questions
What is Opti-Magician Technology Inc.'s FDA import refusal history?
Opti-Magician Technology Inc. (FEI: 3001650549) has 1 FDA import refusal record(s) in our database, spanning from 8/7/2002 to 8/7/2002.
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. Opti-Magician Technology Inc.'s FEI number is 3001650549.
What types of violations has Opti-Magician Technology Inc. received?
Opti-Magician Technology Inc. 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 Opti-Magician Technology Inc. come from?
All FDA import refusal data for Opti-Magician Technology 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.