Patheon Inc.
⚠️ Moderate Risk
FEI: 3003516812 • Whitby, Ontario • CANADA
FEI Number
3003516812
Location
Whitby, Ontario
Country
CANADAAddress
111 Consumers Dr, , Whitby, 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).
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/28/2022 | 66YIB99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/28/2022 | 66YIB99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/4/2019 | 61CIA99ANTI-ANEMIC, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/20/2018 | 64LDY44METHYLPREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/28/2015 | 65VCA56ZOLPIDEM TARTRATE (SEDATIVE) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 5/28/2015 | 65VCA56ZOLPIDEM TARTRATE (SEDATIVE) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 6/18/2012 | 60SIE99ANTACID, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 9/26/2011 | 55QY26HYDROPHILIC PETROLATUM (PHARMACEUTIC NECESSITY - ABSORBENT) | New Orleans District Office (NOL-DO) | |
| 5/13/2011 | 55RP45SORBITOL (PHARMACEUTIC NECESSITY - TABLET EXCIPIENT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/5/2009 | 60CBY09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/21/2009 | 60CIB09PHENYLEPHRINE HCL (ADRENERGIC) | New Orleans District Office (NOL-DO) | |
| 1/28/2008 | 66VIS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/8/2005 | 60LBR01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/17/2003 | 56GCY99ANTIFUNGAL N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Patheon Inc.'s FDA import refusal history?
Patheon Inc. (FEI: 3003516812) has 14 FDA import refusal record(s) in our database, spanning from 9/17/2003 to 7/28/2022.
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 3003516812.
What types of violations has Patheon Inc. received?
Patheon Inc. 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 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.