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Hoya Optical Labs of America Inc.

⚠️ Moderate Risk

FEI: 2124545 • Ramsey, MN • UNITED STATES

FEI

FEI Number

2124545

📍

Location

Ramsey, MN

🇺🇸
🏢

Address

7000 Sunwood Dr Nw, , Ramsey, MN, United States

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/15/2002
Latest Refusal
4/15/2002
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

2351×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
4/15/2002
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Hoya Optical Labs of America Inc.'s FDA import refusal history?

Hoya Optical Labs of America Inc. (FEI: 2124545) has 1 FDA import refusal record(s) in our database, spanning from 4/15/2002 to 4/15/2002.

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. Hoya Optical Labs of America Inc.'s FEI number is 2124545.

What types of violations has Hoya Optical Labs of America Inc. received?

Hoya Optical Labs of America Inc. 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 Hoya Optical Labs of America Inc. come from?

All FDA import refusal data for Hoya Optical Labs of America Inc. 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.