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SILIMED IND. DE IMPLANTES LTDA

⚠️ Moderate Risk

FEI: 3013416217 • Rio de Janeiro, Rio de Janeiro • BRAZIL

FEI

FEI Number

3013416217

📍

Location

Rio de Janeiro, Rio de Janeiro

🇧🇷

Country

BRAZIL
🏢

Address

Rua Figueiredo Rocha 3, , Rio de Janeiro, Rio de Janeiro, Brazil

Moderate Risk

FDA Import Risk Assessment

39.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
3/27/2023
Latest Refusal
3/27/2023
Earliest Refusal

Score Breakdown

Violation Severity
73.3×40%
Refusal Volume
11.2×30%
Recency
30.1×20%
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).

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
3/27/2023
79FWMPROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
118NOT LISTED
237NO PMA
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SILIMED IND. DE IMPLANTES LTDA's FDA import refusal history?

SILIMED IND. DE IMPLANTES LTDA (FEI: 3013416217) has 1 FDA import refusal record(s) in our database, spanning from 3/27/2023 to 3/27/2023.

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. SILIMED IND. DE IMPLANTES LTDA's FEI number is 3013416217.

What types of violations has SILIMED IND. DE IMPLANTES LTDA received?

SILIMED IND. DE IMPLANTES LTDA has been cited for 3 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 SILIMED IND. DE IMPLANTES LTDA come from?

All FDA import refusal data for SILIMED IND. DE IMPLANTES 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.