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Osram Gmbh

⚠️ Moderate Risk

FEI: 2202 • Munich, Bavaria • GERMANY

FEI

FEI Number

2202

📍

Location

Munich, Bavaria

🇩🇪

Country

GERMANY
🏢

Address

Pb 900620, Hellabrunner Str. 1, Munich, Bavaria, Germany

Moderate Risk

FDA Import Risk Assessment

35.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
2/21/2012
Latest Refusal
2/21/2012
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4764×

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).

Refusal History

DateProductViolationsDivision
2/21/2012
95RDYMETAL HALIDE LAMP, MERCURY VAPOR LAMPS
476NO REGISTR
Florida District Office (FLA-DO)
2/21/2012
95RGOUV CURING, NONCOHERENT LIGHT SOURCE, ULTRAVIOLET COMMERCIAL/CONSUMER
476NO REGISTR
Florida District Office (FLA-DO)
2/21/2012
95RDYMETAL HALIDE LAMP, MERCURY VAPOR LAMPS
476NO REGISTR
Florida District Office (FLA-DO)
2/21/2012
95RDYMETAL HALIDE LAMP, MERCURY VAPOR LAMPS
476NO REGISTR
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Osram Gmbh's FDA import refusal history?

Osram Gmbh (FEI: 2202) has 4 FDA import refusal record(s) in our database, spanning from 2/21/2012 to 2/21/2012.

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. Osram Gmbh's FEI number is 2202.

What types of violations has Osram Gmbh received?

Osram Gmbh 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 Osram Gmbh come from?

All FDA import refusal data for Osram 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.