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ONETOP FOODBIOTECH CO., LTD

⚠️ Moderate Risk

FEI: 3014548368 • New Taipei City • TAIWAN

FEI

FEI Number

3014548368

📍

Location

New Taipei City

🇹🇼

Country

TAIWAN
🏢

Address

3 F, Ziyou St.; No. 15 Tucheng Dist., New Taipei City, , Taiwan

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
2
Unique Violations
7/1/2019
Latest Refusal
7/1/2019
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2603×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

33003×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

Refusal History

DateProductViolationsDivision
7/1/2019
31KGT99TEA, N.E.C.
260FALSE
3300ALLERGEN
Division of West Coast Imports (DWCI)
7/1/2019
31MGT99BLENDED TEAS, N.E.C.
260FALSE
3300ALLERGEN
Division of West Coast Imports (DWCI)
7/1/2019
25LGT23TARO, DASHEEN DRIED OR PASTE
260FALSE
3300ALLERGEN
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is ONETOP FOODBIOTECH CO., LTD's FDA import refusal history?

ONETOP FOODBIOTECH CO., LTD (FEI: 3014548368) has 3 FDA import refusal record(s) in our database, spanning from 7/1/2019 to 7/1/2019.

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. ONETOP FOODBIOTECH CO., LTD's FEI number is 3014548368.

What types of violations has ONETOP FOODBIOTECH CO., LTD received?

ONETOP FOODBIOTECH CO., LTD 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 ONETOP FOODBIOTECH CO., LTD come from?

All FDA import refusal data for ONETOP FOODBIOTECH CO., LTD 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.