Hoffman-Laroche Limited
⚠️ Moderate Risk
FEI: 3002408898 • Mississauga, Ontario • CANADA
FEI Number
3002408898
Location
Mississauga, Ontario
Country
CANADAAddress
2455 Meadowpine Blvd, , Mississauga, Ontario, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/14/2009 | 62VIA12RIBAVIRIN (ANTI-VIRAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 12/14/2009 | 62VIA12RIBAVIRIN (ANTI-VIRAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 10/22/2009 | 64XDB11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/4/2009 | 62VBA45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/29/2009 | 64XCB11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/21/2008 | 62GDA49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/26/2004 | 61TCA99ANTI-EMETIC/NAUSEANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/12/2004 | 64XCF11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/12/2002 | 61NAY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Hoffman-Laroche Limited's FDA import refusal history?
Hoffman-Laroche Limited (FEI: 3002408898) has 9 FDA import refusal record(s) in our database, spanning from 2/12/2002 to 12/14/2009.
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. Hoffman-Laroche Limited's FEI number is 3002408898.
What types of violations has Hoffman-Laroche Limited received?
Hoffman-Laroche Limited 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 Hoffman-Laroche Limited come from?
All FDA import refusal data for Hoffman-Laroche Limited 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.