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Peter Gulow

⚠️ Moderate Risk

FEI: 3009179005 • Friedberg (hessen), Hessen • GERMANY

FEI

FEI Number

3009179005

📍

Location

Friedberg (hessen), Hessen

🇩🇪

Country

GERMANY
🏢

Address

Birkenstrase 7a, , Friedberg (hessen), Hessen, Germany

Moderate Risk

FDA Import Risk Assessment

47.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
11/8/2011
Latest Refusal
11/8/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

754×

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
11/8/2011
60LCY84LEFLUNOMIDE (ANALGESIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/8/2011
62GCY59PIROXICAM (ANTI-INFLAMMATORY)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/8/2011
64LCY50PREDNISOLONE (GLUCOCORTICOID)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/8/2011
62TCY07PANTOPRAZOLE SODIUM
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Peter Gulow's FDA import refusal history?

Peter Gulow (FEI: 3009179005) has 4 FDA import refusal record(s) in our database, spanning from 11/8/2011 to 11/8/2011.

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. Peter Gulow's FEI number is 3009179005.

What types of violations has Peter Gulow received?

Peter Gulow 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 Peter Gulow come from?

All FDA import refusal data for Peter Gulow 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.