Patheon Inc.
⚠️ Moderate Risk
FEI: 3002807082 • North York, On • CANADA
FEI Number
3002807082
Location
North York, On
Country
CANADAAddress
Toronto York Mills Operations, 865 York Mills Rd, North York, On, 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).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/15/2007 | 61GCJ06NEOMYCIN PALMITATE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/5/2006 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/22/2006 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 5/5/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/21/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | New York District Office (NYK-DO) |
| 2/15/2005 | 64LDJ45METHYLPREDNISOLONE ACETATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 4/13/2004 | 64LDL45METHYLPREDNISOLONE ACETATE (GLUCOCORTICOID) | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 12/30/2003 | 64LDO45METHYLPREDNISOLONE ACETATE (GLUCOCORTICOID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Patheon Inc.'s FDA import refusal history?
Patheon Inc. (FEI: 3002807082) has 8 FDA import refusal record(s) in our database, spanning from 12/30/2003 to 8/15/2007.
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. Patheon Inc.'s FEI number is 3002807082.
What types of violations has Patheon Inc. received?
Patheon Inc. has been cited for 3 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 Patheon Inc. come from?
All FDA import refusal data for Patheon Inc. 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.