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BINA LIMITED

Low Risk

FEI: 3012627824 • Corozal, Belize • BELIZE

FEI

FEI Number

3012627824

📍

Location

Corozal, Belize

🇧🇿

Country

BELIZE
🏢

Address

Freedom Avenue, Kunal Plaza, Corozal, Belize, Belize

Low Risk

FDA Import Risk Assessment

21.7
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

3
Total Refusals
1
Unique Violations
9/8/2010
Latest Refusal
9/8/2010
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3413×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
9/8/2010
76EMNSCALER, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/8/2010
76EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING
341REGISTERED
Florida District Office (FLA-DO)
9/8/2010
76EFWTOOTHBRUSH, MANUAL
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is BINA LIMITED's FDA import refusal history?

BINA LIMITED (FEI: 3012627824) has 3 FDA import refusal record(s) in our database, spanning from 9/8/2010 to 9/8/2010.

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. BINA LIMITED's FEI number is 3012627824.

What types of violations has BINA LIMITED received?

BINA LIMITED 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 BINA LIMITED come from?

All FDA import refusal data for BINA LIMITED 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.