Catalent Ontario Limited
⚠️ Moderate Risk
FEI: 3000118564 • Windsor, Ontario • CANADA
FEI Number
3000118564
Location
Windsor, Ontario
Country
CANADAAddress
2125 Ambassador Dr, , Windsor, 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
INSANITARY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
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 |
|---|---|---|---|
| 1/18/2006 | 54HDH04FISH OIL (FATS AND LIPID SUBSTANCES) | 306INSANITARY | New York District Office (NYK-DO) |
| 1/18/2006 | 54HDH04FISH OIL (FATS AND LIPID SUBSTANCES) | 306INSANITARY | New York District Office (NYK-DO) |
| 12/3/2003 | 62GQY90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Catalent Ontario Limited's FDA import refusal history?
Catalent Ontario Limited (FEI: 3000118564) has 3 FDA import refusal record(s) in our database, spanning from 12/3/2003 to 1/18/2006.
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. Catalent Ontario Limited's FEI number is 3000118564.
What types of violations has Catalent Ontario Limited received?
Catalent Ontario 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 Catalent Ontario Limited come from?
All FDA import refusal data for Catalent Ontario 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.