ImportRefusal LogoImportRefusal

MALKY LEFKOWITZ

⚠️ Moderate Risk

FEI: 3020824557 • Sainte-Therese, Quebec • CANADA

FEI

FEI Number

3020824557

📍

Location

Sainte-Therese, Quebec

🇨🇦

Country

CANADA
🏢

Address

55 Sicard St, , Sainte-Therese, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

42.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/4/2022
Latest Refusal
5/4/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
12.2×20%
Frequency
10.0×10%
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

751×

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
5/4/2022
62FIK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is MALKY LEFKOWITZ's FDA import refusal history?

MALKY LEFKOWITZ (FEI: 3020824557) has 1 FDA import refusal record(s) in our database, spanning from 5/4/2022 to 5/4/2022.

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. MALKY LEFKOWITZ's FEI number is 3020824557.

What types of violations has MALKY LEFKOWITZ received?

MALKY LEFKOWITZ 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 MALKY LEFKOWITZ come from?

All FDA import refusal data for MALKY LEFKOWITZ 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.