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Rentschler Biopharma SE

⚠️ Moderate Risk

FEI: 1000291122 • Laupheim, Baden-Wurttemberg • GERMANY

FEI

FEI Number

1000291122

📍

Location

Laupheim, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Erwin-Rentschler-Str. 21, , Laupheim, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/28/2012
Latest Refusal
6/28/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

751×

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
6/28/2012
66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Rentschler Biopharma SE's FDA import refusal history?

Rentschler Biopharma SE (FEI: 1000291122) has 1 FDA import refusal record(s) in our database, spanning from 6/28/2012 to 6/28/2012.

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. Rentschler Biopharma SE's FEI number is 1000291122.

What types of violations has Rentschler Biopharma SE received?

Rentschler Biopharma SE 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 Rentschler Biopharma SE come from?

All FDA import refusal data for Rentschler Biopharma SE 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.