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Roche Farma Sa

⚠️ Moderate Risk

FEI: 3004905736 • Madrid, Madrid • SPAIN

FEI

FEI Number

3004905736

📍

Location

Madrid, Madrid

🇪🇸

Country

SPAIN
🏢

Address

Calle Eucaliptos 33, , Madrid, Madrid, Spain

Moderate Risk

FDA Import Risk Assessment

36.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/26/2011
Latest Refusal
9/29/2008
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
6.5×10%
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

752×

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).

1181×

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).

Refusal History

DateProductViolationsDivision
10/26/2011
66MCH75BROMAZEPAM (TRANQUILIZER)
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/29/2008
62CDB99ANTI-HYPERTENSIVE N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Roche Farma Sa's FDA import refusal history?

Roche Farma Sa (FEI: 3004905736) has 2 FDA import refusal record(s) in our database, spanning from 9/29/2008 to 10/26/2011.

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. Roche Farma Sa's FEI number is 3004905736.

What types of violations has Roche Farma Sa received?

Roche Farma Sa 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 Roche Farma Sa come from?

All FDA import refusal data for Roche Farma Sa 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.