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BL Industria Otica, Ltda.

⚠️ Moderate Risk

FEI: 3003032546 • Porto Alegre, RS • BRAZIL

FEI

FEI Number

3003032546

📍

Location

Porto Alegre, RS

🇧🇷

Country

BRAZIL
🏢

Address

Rua Dona Alzira, 139, , Porto Alegre, RS, Brazil

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
2
Unique Violations
6/6/2005
Latest Refusal
6/6/2005
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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.

Refusal History

DateProductViolationsDivision
6/6/2005
86HQLLENS, INTRAOCULAR
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)

Frequently Asked Questions

What is BL Industria Otica, Ltda.'s FDA import refusal history?

BL Industria Otica, Ltda. (FEI: 3003032546) has 1 FDA import refusal record(s) in our database, spanning from 6/6/2005 to 6/6/2005.

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. BL Industria Otica, Ltda.'s FEI number is 3003032546.

What types of violations has BL Industria Otica, Ltda. received?

BL Industria Otica, Ltda. 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 BL Industria Otica, Ltda. come from?

All FDA import refusal data for BL Industria Otica, Ltda. 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.