Bioptik Technology
⚠️ Moderate Risk
FEI: 3009253371 • Miaoli Hsien • TAIWAN
FEI Number
3009253371
Location
Miaoli Hsien
Country
TAIWANAddress
Unknown Street, , Miaoli Hsien, , 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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
Frequently Asked Questions
What is Bioptik Technology's FDA import refusal history?
Bioptik Technology (FEI: 3009253371) has 1 FDA import refusal record(s) in our database, spanning from 7/3/2012 to 7/3/2012.
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. Bioptik Technology's FEI number is 3009253371.
What types of violations has Bioptik Technology received?
Bioptik Technology 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 Bioptik Technology come from?
All FDA import refusal data for Bioptik Technology 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.