Novartis Consumer Health Canada, Inc.
⚠️ Moderate Risk
FEI: 3002616705 • Mississauga, Ontario • CANADA
FEI Number
3002616705
Location
Mississauga, Ontario
Country
CANADAAddress
2233 Argentia Rd Suite 205, , Mississauga, 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).
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.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/8/2016 | 62GAO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/29/2012 | 62UCY99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/30/2012 | 68YIS20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | New Orleans District Office (NOL-DO) | |
| 3/30/2012 | 68YIS20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | New Orleans District Office (NOL-DO) | |
| 3/30/2012 | 68YIS20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | New Orleans District Office (NOL-DO) | |
| 10/5/2011 | 62GBO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/9/2010 | 60CAL53XYLOMETAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/8/2009 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | New York District Office (NYK-DO) |
| 10/26/2007 | 66NCA07OXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/15/2005 | 65LAJ16HYDROXYPROPYL CELLULOSE (PROTECTANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/20/2005 | 63XDH99DIAGOSTIC AID (DRUGS) N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 1/20/2005 | 63XDZ99DIAGOSTIC AID (DRUGS) N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 6/23/2004 | 66BAY99STIMULANT N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/16/2004 | 61EDK14KETOTIFEN FUMERATE (ANTI-ASTHMATIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/23/2003 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Novartis Consumer Health Canada, Inc.'s FDA import refusal history?
Novartis Consumer Health Canada, Inc. (FEI: 3002616705) has 15 FDA import refusal record(s) in our database, spanning from 12/23/2003 to 8/8/2016.
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. Novartis Consumer Health Canada, Inc.'s FEI number is 3002616705.
What types of violations has Novartis Consumer Health Canada, Inc. received?
Novartis Consumer Health Canada, 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 Novartis Consumer Health Canada, Inc. come from?
All FDA import refusal data for Novartis Consumer Health Canada, 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.