Patheon Inc. - Burlington Century Operations
⚠️ Moderate Risk
FEI: 3002861690 • Burlington, Ontario • CANADA
FEI Number
3002861690
Location
Burlington, Ontario
Country
CANADAAddress
977 Century Dr, , Burlington, 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
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 7/16/2007 | 64SCA29ZOPICLONE | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 8/29/2005 | 45LG99FLAVORING AGENTS AND ADJUVANTS (FOOD ADDITIVES FOR HUMAN USE) | 218LIST INGRE | New York District Office (NYK-DO) |
| 8/29/2005 | 45LG99FLAVORING AGENTS AND ADJUVANTS (FOOD ADDITIVES FOR HUMAN USE) | 218LIST INGRE | New York District Office (NYK-DO) |
| 1/7/2002 | 21NYY99IMITATION FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Patheon Inc. - Burlington Century Operations's FDA import refusal history?
Patheon Inc. - Burlington Century Operations (FEI: 3002861690) has 4 FDA import refusal record(s) in our database, spanning from 1/7/2002 to 7/16/2007.
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. - Burlington Century Operations's FEI number is 3002861690.
What types of violations has Patheon Inc. - Burlington Century Operations received?
Patheon Inc. - Burlington Century Operations 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. - Burlington Century Operations come from?
All FDA import refusal data for Patheon Inc. - Burlington Century Operations 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.