Wem Equipamentos Electronicos Lt

⚠️ Moderate Risk

FEI: 3009050625 • Sao Paolo • BRAZIL

FEI

FEI Number

3009050625

📍

Location

Sao Paolo

🇧🇷

Country

BRAZIL

🏢

Address

Rua Mal Mascarehas D Morales, , Sao Paolo, , Brazil

Moderate Risk

FDA Import Risk Assessment

32.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/15/2011

Latest Refusal

9/16/2011

Earliest Refusal

Score Breakdown

Violation Severity

42.0×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

60.0×10%

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

Violation Summary

3416×

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).

1182×

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).

5082×

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

Date	Product	Violations	Division
11/15/2011	79DWGELECTROSURGICAL DEVICE	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/15/2011	79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
9/16/2011	89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT	341REGISTERED	Division of Southeast Imports (DSEI)
9/16/2011	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED	Division of Southeast Imports (DSEI)
9/16/2011	89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT	341REGISTERED	Division of Southeast Imports (DSEI)
9/16/2011	79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	341REGISTERED	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Wem Equipamentos Electronicos Lt's FDA import refusal history?

Wem Equipamentos Electronicos Lt (FEI: 3009050625) has 6 FDA import refusal record(s) in our database, spanning from 9/16/2011 to 11/15/2011.

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. Wem Equipamentos Electronicos Lt's FEI number is 3009050625.

What types of violations has Wem Equipamentos Electronicos Lt received?

Wem Equipamentos Electronicos Lt 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 Wem Equipamentos Electronicos Lt come from?

All FDA import refusal data for Wem Equipamentos Electronicos Lt 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.