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IDT Biologika GmbH

⚠️ Moderate Risk

FEI: 3005001757 • Dessau-Rosslau, Saxony-Anhalt • GERMANY

FEI

FEI Number

3005001757

📍

Location

Dessau-Rosslau, Saxony-Anhalt

🇩🇪

Country

GERMANY
🏢

Address

Dessau-Rosslau, Am Pharmapark, Dessau-Rosslau, Saxony-Anhalt, Germany

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/12/2014
Latest Refusal
2/12/2014
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
2/12/2014
57CH99VIRAL VACCINES, N.E.C.
27DRUG GMPS
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is IDT Biologika GmbH's FDA import refusal history?

IDT Biologika GmbH (FEI: 3005001757) has 1 FDA import refusal record(s) in our database, spanning from 2/12/2014 to 2/12/2014.

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. IDT Biologika GmbH's FEI number is 3005001757.

What types of violations has IDT Biologika GmbH received?

IDT Biologika GmbH 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 IDT Biologika GmbH come from?

All FDA import refusal data for IDT Biologika GmbH 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.