Unaiza Rana
⚠️ High Risk
FEI: 3006685116 • Mississaugamississauga, ON • CANADA
FEI Number
3006685116
Location
Mississaugamississauga, ON
Country
CANADAAddress
1440 Astrella Crescent, , Mississaugamississauga, ON, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/13/2008 | 61JCC14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2008 | 61NCC65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2008 | 56BCC03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2008 | 60XCC17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2008 | 60CCC57PSEUDOEPHEDRINE (ADRENERGIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2008 | 60CCC57PSEUDOEPHEDRINE (ADRENERGIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2008 | 61XCC45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2008 | 62GCC48MEFENAMIC ACID (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2008 | 66TCC01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2008 | 62OCC44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2008 | 62KCC10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2008 | 61NCC76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Unaiza Rana's FDA import refusal history?
Unaiza Rana (FEI: 3006685116) has 12 FDA import refusal record(s) in our database, spanning from 3/13/2008 to 3/13/2008.
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. Unaiza Rana's FEI number is 3006685116.
What types of violations has Unaiza Rana received?
Unaiza Rana has been cited for 1 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 Unaiza Rana come from?
All FDA import refusal data for Unaiza Rana 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.