Contek Life Science
⚠️ Moderate Risk
FEI: 3010231482 • Taipei City, TW-TPE • TAIWAN
FEI Number
3010231482
Location
Taipei City, TW-TPE
Country
TAIWANAddress
Zhongzheng District, NO. 48, 4TH. Floor; Huaining St., Taipei City, TW-TPE, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/5/2019 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/29/2019 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/21/2016 | 61LAS99ANTI-COAGULANT, N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Contek Life Science's FDA import refusal history?
Contek Life Science (FEI: 3010231482) has 3 FDA import refusal record(s) in our database, spanning from 1/21/2016 to 8/5/2019.
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. Contek Life Science's FEI number is 3010231482.
What types of violations has Contek Life Science received?
Contek Life Science 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 Contek Life Science come from?
All FDA import refusal data for Contek Life Science 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.