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Methodos S Pa

⚠️ Moderate Risk

FEI: 3005313676 • Milan, Milan • ITALY

FEI

FEI Number

3005313676

📍

Location

Milan, Milan

🇮🇹

Country

ITALY
🏢

Address

Viale San Michele del Carso 4, , Milan, Milan, Italy

Moderate Risk

FDA Import Risk Assessment

38.6
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
10/31/2005
Latest Refusal
10/31/2005
Earliest Refusal

Score Breakdown

Violation Severity
67.1×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

753×

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
10/31/2005
61LCE99ANTI-COAGULANT, N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
10/31/2005
61LCE99ANTI-COAGULANT, N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
10/31/2005
62BCE99ANTI-HYPERLIPIDEMIC N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
10/31/2005
60LAE99ANALGESIC, N.E.C.
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Methodos S Pa's FDA import refusal history?

Methodos S Pa (FEI: 3005313676) has 4 FDA import refusal record(s) in our database, spanning from 10/31/2005 to 10/31/2005.

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. Methodos S Pa's FEI number is 3005313676.

What types of violations has Methodos S Pa received?

Methodos S Pa has been cited for 2 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 Methodos S Pa come from?

All FDA import refusal data for Methodos S Pa 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.