Productos Roche Quimicos E Farmaceuticos
⚠️ Moderate Risk
FEI: 3002807936 • Jaguare, Espirito Santo • BRAZIL
FEI Number
3002807936
Location
Jaguare, Espirito Santo
Country
BRAZILAddress
Eng. Bilings, 1729, Sao Paolo, Jaguare, Espirito Santo, 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
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).
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).
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 |
|---|---|---|---|
| 1/30/2015 | 61MCB06CLONAZEPAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2011 | 62OCC22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/2/2009 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/9/2008 | 80LDQDEVICE, GENERAL MEDICAL | Division of Southeast Imports (DSEI) | |
| 6/9/2008 | 80LDQDEVICE, GENERAL MEDICAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Productos Roche Quimicos E Farmaceuticos's FDA import refusal history?
Productos Roche Quimicos E Farmaceuticos (FEI: 3002807936) has 5 FDA import refusal record(s) in our database, spanning from 6/9/2008 to 1/30/2015.
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. Productos Roche Quimicos E Farmaceuticos's FEI number is 3002807936.
What types of violations has Productos Roche Quimicos E Farmaceuticos received?
Productos Roche Quimicos E Farmaceuticos 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 Productos Roche Quimicos E Farmaceuticos come from?
All FDA import refusal data for Productos Roche Quimicos E Farmaceuticos 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.