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Fackler

✅ Low Risk

FEI: 3004707061 • Springe, Lower Saxony • GERMANY

FEI

FEI Number

3004707061

📍

Location

Springe, Lower Saxony

🇩🇪

Country

GERMANY
🏢

Address

Philipp-Reis-Str. 3, , Springe, Lower Saxony, Germany

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
10/29/2004
Latest Refusal
10/29/2004
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

3311×

DR QUALITC

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
10/29/2004
62FAB53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL)
331DR QUALITC
472NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Fackler's FDA import refusal history?

Fackler (FEI: 3004707061) has 1 FDA import refusal record(s) in our database, spanning from 10/29/2004 to 10/29/2004.

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. Fackler's FEI number is 3004707061.

What types of violations has Fackler received?

Fackler 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 Fackler come from?

All FDA import refusal data for Fackler 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.