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Optische Werke

⚠️ Moderate Risk

FEI: 1000176520 • Regen • GERMANY

FEI

FEI Number

1000176520

📍

Location

Regen

🇩🇪

Country

GERMANY
🏢

Address

45, , Regen, , Germany

Moderate Risk

FDA Import Risk Assessment

31.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
12/13/2011
Latest Refusal
11/30/2001
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
3.0×10%
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

2353×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

Refusal History

DateProductViolationsDivision
12/13/2011
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)
11/30/2001
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)
11/30/2001
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Optische Werke's FDA import refusal history?

Optische Werke (FEI: 1000176520) has 3 FDA import refusal record(s) in our database, spanning from 11/30/2001 to 12/13/2011.

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. Optische Werke's FEI number is 1000176520.

What types of violations has Optische Werke received?

Optische Werke 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 Optische Werke come from?

All FDA import refusal data for Optische Werke 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.