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Bmi A Keller Gmbh

⚠️ Moderate Risk

FEI: 3009234281 • Hersbruck, Bayern • GERMANY

FEI

FEI Number

3009234281

📍

Location

Hersbruck, Bayern

🇩🇪

Country

GERMANY
🏢

Address

Rosengasse 12, , Hersbruck, Bayern, Germany

Moderate Risk

FDA Import Risk Assessment

32.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
5/3/2012
Latest Refusal
4/23/2012
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

4762×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
5/3/2012
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
4/23/2012
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
47NON STD
476NO REGISTR
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Bmi A Keller Gmbh's FDA import refusal history?

Bmi A Keller Gmbh (FEI: 3009234281) has 2 FDA import refusal record(s) in our database, spanning from 4/23/2012 to 5/3/2012.

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. Bmi A Keller Gmbh's FEI number is 3009234281.

What types of violations has Bmi A Keller Gmbh received?

Bmi A Keller Gmbh 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 Bmi A Keller Gmbh come from?

All FDA import refusal data for Bmi A Keller Gmbh 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.