ImportRefusal LogoImportRefusal

LEM COMPOUNDING RESEARCH ITA SRL

⚠️ Moderate Risk

FEI: 3012991989 • Lentate sul Seveso, Monza E della Brianza • ITALY

FEI

FEI Number

3012991989

📍

Location

Lentate sul Seveso, Monza E della Brianza

🇮🇹

Country

ITALY
🏢

Address

Via Giuseppe Garibaldi 66, , Lentate sul Seveso, Monza E della Brianza, Italy

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/6/2019
Latest Refusal
9/6/2019
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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
9/6/2019
66YDK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is LEM COMPOUNDING RESEARCH ITA SRL's FDA import refusal history?

LEM COMPOUNDING RESEARCH ITA SRL (FEI: 3012991989) has 1 FDA import refusal record(s) in our database, spanning from 9/6/2019 to 9/6/2019.

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. LEM COMPOUNDING RESEARCH ITA SRL's FEI number is 3012991989.

What types of violations has LEM COMPOUNDING RESEARCH ITA SRL received?

LEM COMPOUNDING RESEARCH ITA SRL 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 LEM COMPOUNDING RESEARCH ITA SRL come from?

All FDA import refusal data for LEM COMPOUNDING RESEARCH ITA SRL 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.