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Opticas Devlyn

⚠️ Moderate Risk

FEI: 3004546926 • Col. Bosques De La Sierra, Queretaro • MEXICO

FEI

FEI Number

3004546926

📍

Location

Col. Bosques De La Sierra, Queretaro

🇲🇽

Country

MEXICO
🏢

Address

Bosques De Dovizno 69-203, Jalpan De Serra, Col. Bosques De La Sierra, Queretaro, Mexico

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/21/2004
Latest Refusal
6/21/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

DateProductViolationsDivision
6/21/2004
86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY
508NO 510(K)
84RX DEVICE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Opticas Devlyn's FDA import refusal history?

Opticas Devlyn (FEI: 3004546926) has 1 FDA import refusal record(s) in our database, spanning from 6/21/2004 to 6/21/2004.

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. Opticas Devlyn's FEI number is 3004546926.

What types of violations has Opticas Devlyn received?

Opticas Devlyn has been cited for 2 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 Opticas Devlyn come from?

All FDA import refusal data for Opticas Devlyn 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.