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Cambrex Profarmaco Milano Srl

⚠️ Moderate Risk

FEI: 3003723076 • Paullo, Milan • ITALY

FEI

FEI Number

3003723076

📍

Location

Paullo, Milan

🇮🇹

Country

ITALY
🏢

Address

Via Eugenio Curiel 34, , Paullo, Milan, Italy

Moderate Risk

FDA Import Risk Assessment

34.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
4/11/2019
Latest Refusal
9/2/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
2.0×10%
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

163×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
4/11/2019
64BCS25HYDROCHLOROTHIAZIDE (DIURETIC)
16DIRECTIONS
Division of Northeast Imports (DNEI)
7/26/2018
64BCS25HYDROCHLOROTHIAZIDE (DIURETIC)
16DIRECTIONS
Division of Northeast Imports (DNEI)
9/2/2004
63BCS22TERBUTALINE SULFATE (BRONCHODILATOR)
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Cambrex Profarmaco Milano Srl's FDA import refusal history?

Cambrex Profarmaco Milano Srl (FEI: 3003723076) has 3 FDA import refusal record(s) in our database, spanning from 9/2/2004 to 4/11/2019.

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. Cambrex Profarmaco Milano Srl's FEI number is 3003723076.

What types of violations has Cambrex Profarmaco Milano Srl received?

Cambrex Profarmaco Milano 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 Cambrex Profarmaco Milano Srl come from?

All FDA import refusal data for Cambrex Profarmaco Milano 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.