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Carci Ind. Com. Apar. Ctr Orthoped. Ltd

✅ Low Risk

FEI: 3005182622 • Sao Paulo, SP • BRAZIL

FEI

FEI Number

3005182622

📍

Location

Sao Paulo, SP

🇧🇷

Country

BRAZIL
🏢

Address

Rua Alvares Fagundes 359, , Sao Paulo, SP, Brazil

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
7/11/2005
Latest Refusal
7/11/2005
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
7/11/2005
89IORWHEELCHAIR, MECHANICAL
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Carci Ind. Com. Apar. Ctr Orthoped. Ltd's FDA import refusal history?

Carci Ind. Com. Apar. Ctr Orthoped. Ltd (FEI: 3005182622) has 1 FDA import refusal record(s) in our database, spanning from 7/11/2005 to 7/11/2005.

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. Carci Ind. Com. Apar. Ctr Orthoped. Ltd's FEI number is 3005182622.

What types of violations has Carci Ind. Com. Apar. Ctr Orthoped. Ltd received?

Carci Ind. Com. Apar. Ctr Orthoped. Ltd 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 Carci Ind. Com. Apar. Ctr Orthoped. Ltd come from?

All FDA import refusal data for Carci Ind. Com. Apar. Ctr Orthoped. Ltd 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.