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R.Klass & Co

⚠️ Moderate Risk

FEI: 1000175251 • Bremen, Bremen • GERMANY

FEI

FEI Number

1000175251

📍

Location

Bremen, Bremen

🇩🇪

Country

GERMANY
🏢

Address

Postfach 660340, , Bremen, Bremen, Germany

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
3/18/2002
Latest Refusal
3/18/2002
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
3/18/2002
63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
3/18/2002
63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
3/18/2002
63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is R.Klass & Co's FDA import refusal history?

R.Klass & Co (FEI: 1000175251) has 3 FDA import refusal record(s) in our database, spanning from 3/18/2002 to 3/18/2002.

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. R.Klass & Co's FEI number is 1000175251.

What types of violations has R.Klass & Co received?

R.Klass & Co 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 R.Klass & Co come from?

All FDA import refusal data for R.Klass & Co 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.