Mektec Corporation
⚠️ Moderate Risk
FEI: 3004107092 • Kaohsiung • TAIWAN
FEI Number
3004107092
Location
Kaohsiung
Country
TAIWANAddress
48 Cheng Heng Street, , Kaohsiung, , 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/19/2003 | 64SDA99HYPNOTIC N.E.C. | Cincinnati District Office (CIN-DO) | |
| 8/19/2003 | 62GBO99ANTI-INFLAMMATORY N.E.C. | Cincinnati District Office (CIN-DO) | |
| 8/19/2003 | 62OCA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | Cincinnati District Office (CIN-DO) | |
| 8/19/2003 | 63ADA06RALOXIFENE HCL (BONE CALCIUM REGULATOR) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Mektec Corporation's FDA import refusal history?
Mektec Corporation (FEI: 3004107092) has 4 FDA import refusal record(s) in our database, spanning from 8/19/2003 to 8/19/2003.
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. Mektec Corporation's FEI number is 3004107092.
What types of violations has Mektec Corporation received?
Mektec Corporation 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 Mektec Corporation come from?
All FDA import refusal data for Mektec Corporation 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.