Loewe Opta Gmbh
⚠️ Moderate Risk
FEI: 1000241100 • Kronach • GERMANY
FEI Number
1000241100
Location
Kronach
Country
GERMANYAddress
Industriestrabe 11 Postfact 1554, , Kronach, , Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
Frequently Asked Questions
What is Loewe Opta Gmbh's FDA import refusal history?
Loewe Opta Gmbh (FEI: 1000241100) has 2 FDA import refusal record(s) in our database, spanning from 3/20/2002 to 2/11/2003.
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. Loewe Opta Gmbh's FEI number is 1000241100.
What types of violations has Loewe Opta Gmbh received?
Loewe Opta 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 Loewe Opta Gmbh come from?
All FDA import refusal data for Loewe Opta 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.