Berna J Mendoza
⚠️ Moderate Risk
FEI: 3004167977 • Ottawa, ON • CANADA
FEI Number
3004167977
Location
Ottawa, ON
Country
CANADAAddress
54 Buckingham Private, , Ottawa, ON, Canada
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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2003 | 64UCA03CARBIDOPA (INHIBITOR (DECARBOXYLASE)) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/30/2003 | 61NCA44NORTRIPTYLINE HCL (ANTI-DEPRESSANT) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/28/2003 | 61JCA14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2003 | 62JCA15PRAMIPEXOLE (ANTI-PARKINSONIAN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Berna J Mendoza's FDA import refusal history?
Berna J Mendoza (FEI: 3004167977) has 4 FDA import refusal record(s) in our database, spanning from 10/28/2003 to 10/30/2003.
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. Berna J Mendoza's FEI number is 3004167977.
What types of violations has Berna J Mendoza received?
Berna J Mendoza has been cited for 2 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 Berna J Mendoza come from?
All FDA import refusal data for Berna J Mendoza 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.