Mark Riffel
⚠️ High Risk
FEI: 3005545147 • Saskatoon, SK • CANADA
FEI Number
3005545147
Location
Saskatoon, SK
Country
CANADAAddress
919 Osborne St, , Saskatoon, SK, 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 |
|---|---|---|---|
| 3/27/2006 | 63ADA02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/27/2006 | 61GDA61SULFASALAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/27/2006 | 62GDA51NAPROXOL (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/27/2006 | 62LPA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/27/2006 | 66JDA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/27/2006 | 64BDA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/27/2006 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/27/2006 | 62ODA34FOSINOPRIL SODIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Mark Riffel's FDA import refusal history?
Mark Riffel (FEI: 3005545147) has 8 FDA import refusal record(s) in our database, spanning from 3/27/2006 to 3/27/2006.
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. Mark Riffel's FEI number is 3005545147.
What types of violations has Mark Riffel received?
Mark Riffel 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 Mark Riffel come from?
All FDA import refusal data for Mark Riffel 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.