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Staufen & Pharma

⚠️ Moderate Risk

FEI: 1000277465 • Goppingen, Baden-Wurttemberg • GERMANY

FEI

FEI Number

1000277465

📍

Location

Goppingen, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Bahnhofstr. 35, , Goppingen, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

29.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
9/14/2006
Latest Refusal
10/29/2004
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
10.7×10%
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

3312×

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
9/14/2006
66VAP99MISCELLANEOUS PATENT MEDICINES, ETC.
331DR QUALITC
New Orleans District Office (NOL-DO)
10/29/2004
55PY21SODIUM BORATE (PHARMACEUTIC NECESSITY - ALKALIZING AGENT)
331DR QUALITC
472NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Staufen & Pharma's FDA import refusal history?

Staufen & Pharma (FEI: 1000277465) has 2 FDA import refusal record(s) in our database, spanning from 10/29/2004 to 9/14/2006.

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. Staufen & Pharma's FEI number is 1000277465.

What types of violations has Staufen & Pharma received?

Staufen & Pharma 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 Staufen & Pharma come from?

All FDA import refusal data for Staufen & Pharma 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.