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Safilens Srl

✅ Low Risk

FEI: 3009776334 • Staranzano, Gorizia • ITALY

FEI

FEI Number

3009776334

📍

Location

Staranzano, Gorizia

🇮🇹

Country

ITALY
🏢

Address

Piazza Risiera San Sabba 7, , Staranzano, Gorizia, Italy

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
2
Unique Violations
5/6/2016
Latest Refusal
5/6/2016
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

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

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
5/6/2016
86MVNLENS, CONTACT (DISPOSABLE)
3260NO ENGLISH
341REGISTERED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Safilens Srl's FDA import refusal history?

Safilens Srl (FEI: 3009776334) has 1 FDA import refusal record(s) in our database, spanning from 5/6/2016 to 5/6/2016.

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. Safilens Srl's FEI number is 3009776334.

What types of violations has Safilens Srl received?

Safilens Srl 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 Safilens Srl come from?

All FDA import refusal data for Safilens Srl 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.