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InfoRLife SA

⚠️ Moderate Risk

FEI: 3004537783 • Campascio • SWITZERLAND

FEI

FEI Number

3004537783

📍

Location

Campascio

🇨🇭
🏢

Address

Casai, , Campascio, , Switzerland

Moderate Risk

FDA Import Risk Assessment

47.0
LowModerateHighCritical

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

Statistics

7
Total Refusals
2
Unique Violations
7/30/2015
Latest Refusal
3/13/2013
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
29.4×10%
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

757×

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
7/30/2015
61MCZ11MAGNESIUM SULFATE (ANTI-CONVULSANT)
118NOT LISTED
75UNAPPROVED
Atlanta District Office (ATL-DO)
3/13/2013
62ACK05ZOLEDRONIC ACID
75UNAPPROVED
New Orleans District Office (NOL-DO)
3/13/2013
62ACK05ZOLEDRONIC ACID
75UNAPPROVED
New Orleans District Office (NOL-DO)
3/13/2013
62ACK05ZOLEDRONIC ACID
75UNAPPROVED
New Orleans District Office (NOL-DO)
3/13/2013
62ACK05ZOLEDRONIC ACID
75UNAPPROVED
New Orleans District Office (NOL-DO)
3/13/2013
62ACK05ZOLEDRONIC ACID
75UNAPPROVED
New Orleans District Office (NOL-DO)
3/13/2013
62ACK05ZOLEDRONIC ACID
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is InfoRLife SA's FDA import refusal history?

InfoRLife SA (FEI: 3004537783) has 7 FDA import refusal record(s) in our database, spanning from 3/13/2013 to 7/30/2015.

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. InfoRLife SA's FEI number is 3004537783.

What types of violations has InfoRLife SA received?

InfoRLife 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 InfoRLife SA come from?

All FDA import refusal data for InfoRLife 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.