Patheon Inc.
⚠️ High Risk
FEI: 3000264888 • Mississauga, Ontario • CANADA
FEI Number
3000264888
Location
Mississauga, Ontario
Country
CANADAAddress
2100 Syntex Crt, , Mississauga, Ontario, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/9/2025 | 62VDY15TENOFOVIR DISOPROXIL FUMERATE | Division of Southeast Imports (DSEI) | |
| 4/23/2018 | 61BIA99ANTI-ANDROGEN, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/9/2016 | 61NDA74MODAFINIL (ANTI-DEPRESSANT) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 9/3/2015 | 56JIZ99LINCOMYCIN N.E.C. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/23/2015 | 64GDA27DESOGESTREL/ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/27/2014 | 61TDC99ANTI-EMETIC/NAUSEANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/7/2013 | 64UIE99INHIBITOR N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 8/7/2013 | 64UIE99INHIBITOR N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 7/24/2013 | 64UIA99INHIBITOR N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/24/2013 | 64UIA99INHIBITOR N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/29/2013 | 64UIS99INHIBITOR N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/10/2012 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | Chicago District Office (CHI-DO) | |
| 1/11/2012 | 62NCH03ACITRETIN (ANTI-PSORIATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 63NCB21PILOCARPINE HCL (CHOLINERGIC) | New Orleans District Office (NOL-DO) | |
| 11/16/2011 | 62VIA99ANTI-VIRAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/5/2011 | 62VIA99ANTI-VIRAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/8/2010 | 62IIA99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/5/2008 | 64LDJ45METHYLPREDNISOLONE ACETATE (GLUCOCORTICOID) | Los Angeles District Office (LOS-DO) | |
| 7/19/2006 | 62VDB31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/5/2006 | 62VCB31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/5/2006 | 62VCB31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/5/2006 | 62VCB31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/5/2006 | 62VCB31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/10/2006 | 63NIA25URSODIOL (CHOLINERGIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 9/3/2005 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2005 | 62GIZ99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/22/2005 | 63XDY99DIAGOSTIC AID (DRUGS) N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/24/2005 | 66VIA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 12/27/2004 | 64SDA99HYPNOTIC N.E.C. | Detroit District Office (DET-DO) | |
| 5/2/2002 | 68YIB99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | New York District Office (NYK-DO) |
| 5/2/2002 | 68YIB99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | New York District Office (NYK-DO) |
| 3/28/2002 | 62VDY31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/28/2002 | 62VDY31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/9/2002 | 62VDY31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/6/2002 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 483DRUG NAME | New Orleans District Office (NOL-DO) |
| 3/6/2002 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 483DRUG NAME | New Orleans District Office (NOL-DO) |
| 2/23/2002 | 62VBY31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Patheon Inc.'s FDA import refusal history?
Patheon Inc. (FEI: 3000264888) has 37 FDA import refusal record(s) in our database, spanning from 2/23/2002 to 4/9/2025.
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 3000264888.
What types of violations has Patheon Inc. received?
Patheon Inc. has been cited for 5 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.