Wem Equipamentos
⚠️ Moderate Risk
FEI: 3004113236 • Ribeirao Preto, SP • BRAZIL
FEI Number
3004113236
Location
Ribeirao Preto, SP
Country
BRAZILAddress
550 Street, , Ribeirao Preto, SP, Brazil
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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).
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 |
|---|---|---|---|
| 8/17/2010 | 80FRKCHAIR, EXAMINATION AND TREATMENT | Florida District Office (FLA-DO) | |
| 8/17/2010 | 79DWGELECTROSURGICAL DEVICE | Florida District Office (FLA-DO) | |
| 8/17/2010 | 79NUJELECTROSURGICAL, CUTTING & COAGULATION, ACCESSORIES LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED | Florida District Office (FLA-DO) | |
| 8/17/2010 | 79DWGELECTROSURGICAL DEVICE | Florida District Office (FLA-DO) | |
| 8/17/2010 | 79NUJELECTROSURGICAL, CUTTING & COAGULATION, ACCESSORIES LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED | Florida District Office (FLA-DO) | |
| 8/17/2010 | 79DWGELECTROSURGICAL DEVICE | Florida District Office (FLA-DO) | |
| 8/17/2010 | 79DWGELECTROSURGICAL DEVICE | Florida District Office (FLA-DO) | |
| 9/29/2004 | 79MDWINSTRUMENT, MANUAL, SURGICAL, GENERAL USE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Wem Equipamentos's FDA import refusal history?
Wem Equipamentos (FEI: 3004113236) has 8 FDA import refusal record(s) in our database, spanning from 9/29/2004 to 8/17/2010.
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's FEI number is 3004113236.
What types of violations has Wem Equipamentos received?
Wem Equipamentos 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 come from?
All FDA import refusal data for Wem Equipamentos 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.