Yves Roche Canada Ltee
⚠️ Moderate Risk
FEI: 3000178198 • Longueuil, QC • CANADA
FEI Number
3000178198
Location
Longueuil, QC
Country
CANADAAddress
789 Jean-Paul-Vincent, , Longueuil, QC, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2002 | 66PBJ06OCTABENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/22/2002 | 62WBJ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/22/2002 | 62WBJ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/22/2002 | 62WBJ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/22/2002 | 62WBJ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/22/2002 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/22/2002 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/22/2002 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/22/2002 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Yves Roche Canada Ltee's FDA import refusal history?
Yves Roche Canada Ltee (FEI: 3000178198) has 9 FDA import refusal record(s) in our database, spanning from 8/22/2002 to 8/22/2002.
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. Yves Roche Canada Ltee's FEI number is 3000178198.
What types of violations has Yves Roche Canada Ltee received?
Yves Roche Canada Ltee 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 Yves Roche Canada Ltee come from?
All FDA import refusal data for Yves Roche Canada Ltee 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.