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Hyline Label Co Ltd

⚠️ High Risk

FEI: 3004720781 • Trinidad • TRINIDAD AND TOBAGO

FEI

FEI Number

3004720781

📍

Location

Trinidad

🇹🇹
🏢

Address

Sadhoo Trace El,Socorro San Juan, , Trinidad, , Trinidad and Tobago

High Risk

FDA Import Risk Assessment

50.3
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
1
Unique Violations
7/13/2023
Latest Refusal
7/13/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
34.7×20%
Frequency
20.0×10%
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

752×

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).

Refusal History

DateProductViolationsDivision
7/13/2023
64NAA08IRON SORBITEX (HEMATINIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/13/2023
60LAJ07CAMPHORATED OIL
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Hyline Label Co Ltd's FDA import refusal history?

Hyline Label Co Ltd (FEI: 3004720781) has 2 FDA import refusal record(s) in our database, spanning from 7/13/2023 to 7/13/2023.

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. Hyline Label Co Ltd's FEI number is 3004720781.

What types of violations has Hyline Label Co Ltd received?

Hyline Label Co Ltd has been cited for 1 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 Hyline Label Co Ltd come from?

All FDA import refusal data for Hyline Label 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.