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Gebauer Company

⚠️ Moderate Risk

FEI: 1519179 • Cleveland, OH • UNITED STATES

FEI

FEI Number

1519179

📍

Location

Cleveland, OH

🇺🇸
🏢

Address

4444 E 153rd St, , Cleveland, OH, United States

Moderate Risk

FDA Import Risk Assessment

30.6
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
5/25/2006
Latest Refusal
5/25/2006
Earliest Refusal

Score Breakdown

Violation Severity
47.1×40%
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

3414×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

24803×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
5/25/2006
89MLYREFRIGERANT, TOPICAL (VAPOCOLLANT)
2480RXPERSONAL
341REGISTERED
New York District Office (NYK-DO)
5/25/2006
89MLYREFRIGERANT, TOPICAL (VAPOCOLLANT)
2480RXPERSONAL
341REGISTERED
New York District Office (NYK-DO)
5/25/2006
89MLYREFRIGERANT, TOPICAL (VAPOCOLLANT)
2480RXPERSONAL
341REGISTERED
New York District Office (NYK-DO)
5/25/2006
89MLYREFRIGERANT, TOPICAL (VAPOCOLLANT)
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Gebauer Company's FDA import refusal history?

Gebauer Company (FEI: 1519179) has 4 FDA import refusal record(s) in our database, spanning from 5/25/2006 to 5/25/2006.

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. Gebauer Company's FEI number is 1519179.

What types of violations has Gebauer Company received?

Gebauer Company 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 Gebauer Company come from?

All FDA import refusal data for Gebauer Company 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.