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Polimeros Opticos De Mexico, S.A.

✅ Low Risk

FEI: 3003219511 • Monterrey, NL • MEXICO

FEI

FEI Number

3003219511

📍

Location

Monterrey, NL

🇲🇽

Country

MEXICO
🏢

Address

Antonio Coello 626-F Col. Obrera, , Monterrey, NL, Mexico

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
1/3/2002
Latest Refusal
1/3/2002
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
1/3/2002
86HQZFRAME, SPECTACLE
341REGISTERED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Polimeros Opticos De Mexico, S.A.'s FDA import refusal history?

Polimeros Opticos De Mexico, S.A. (FEI: 3003219511) has 1 FDA import refusal record(s) in our database, spanning from 1/3/2002 to 1/3/2002.

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. Polimeros Opticos De Mexico, S.A.'s FEI number is 3003219511.

What types of violations has Polimeros Opticos De Mexico, S.A. received?

Polimeros Opticos De Mexico, S.A. 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 Polimeros Opticos De Mexico, S.A. come from?

All FDA import refusal data for Polimeros Opticos De Mexico, S.A. 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.