Instramed Industria Medico Hospitalar Ltda
⚠️ Moderate Risk
FEI: 3008463212 • Porto Alegre, Rio Grande do sul • BRAZIL
FEI Number
3008463212
Location
Porto Alegre, Rio Grande do sul
Country
BRAZILAddress
Beco Jose Paris 339, , Porto Alegre, Rio Grande do sul, 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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/7/2019 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Division of Southeast Imports (DSEI) | |
| 9/3/2013 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 9/3/2013 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Florida District Office (FLA-DO) | |
| 8/16/2013 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Florida District Office (FLA-DO) | |
| 8/16/2013 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Florida District Office (FLA-DO) | |
| 8/6/2012 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Florida District Office (FLA-DO) | |
| 8/3/2012 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Florida District Office (FLA-DO) | |
| 8/3/2012 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Instramed Industria Medico Hospitalar Ltda's FDA import refusal history?
Instramed Industria Medico Hospitalar Ltda (FEI: 3008463212) has 8 FDA import refusal record(s) in our database, spanning from 8/3/2012 to 6/7/2019.
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. Instramed Industria Medico Hospitalar Ltda's FEI number is 3008463212.
What types of violations has Instramed Industria Medico Hospitalar Ltda received?
Instramed Industria Medico Hospitalar Ltda has been cited for 4 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 Instramed Industria Medico Hospitalar Ltda come from?
All FDA import refusal data for Instramed Industria Medico Hospitalar 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.