Odan Laboratories Ltd
⚠️ Moderate Risk
FEI: 3002706162 • Pointe-Claire, Quebec • CANADA
FEI Number
3002706162
Location
Pointe-Claire, Quebec
Country
CANADAAddress
325 Stillview Ave, , Pointe-Claire, Quebec, 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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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).
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 |
|---|---|---|---|
| 8/26/2011 | 66FCA05COLCHICINE (SUPPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 66FDB05COLCHICINE (SUPPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/5/2006 | 60QDQ40LIDOCAINE HCL (ANESTHETIC) | New York District Office (NYK-DO) | |
| 1/12/2006 | 60QDQ40LIDOCAINE HCL (ANESTHETIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Odan Laboratories Ltd's FDA import refusal history?
Odan Laboratories Ltd (FEI: 3002706162) has 4 FDA import refusal record(s) in our database, spanning from 1/12/2006 to 8/26/2011.
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. Odan Laboratories Ltd's FEI number is 3002706162.
What types of violations has Odan Laboratories Ltd received?
Odan Laboratories Ltd has been cited for 4 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 Odan Laboratories Ltd come from?
All FDA import refusal data for Odan Laboratories Ltd 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.