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Janssen Cilag Spa

⚠️ Moderate Risk

FEI: 3003529605 • Roma, RM • ITALY

FEI

FEI Number

3003529605

📍

Location

Roma, RM

🇮🇹

Country

ITALY
🏢

Address

Viale Castello Della Magliana 38, , Roma, RM, Italy

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
6/26/2006
Latest Refusal
6/26/2006
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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
6/26/2006
62SAL99ANTI-SEBORRHEIC N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
6/26/2006
62SAL99ANTI-SEBORRHEIC N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
6/26/2006
62SAL99ANTI-SEBORRHEIC N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Janssen Cilag Spa's FDA import refusal history?

Janssen Cilag Spa (FEI: 3003529605) has 3 FDA import refusal record(s) in our database, spanning from 6/26/2006 to 6/26/2006.

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. Janssen Cilag Spa's FEI number is 3003529605.

What types of violations has Janssen Cilag Spa received?

Janssen Cilag Spa 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 Janssen Cilag Spa come from?

All FDA import refusal data for Janssen Cilag Spa 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.