Cobalt Pharmaceuticals, Inc.
⚠️ Moderate Risk
FEI: 3003989770 • Mississauga, Ontario • CANADA
FEI Number
3003989770
Location
Mississauga, Ontario
Country
CANADAAddress
6500 Kitimat Rd, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/25/2013 | 64TCA04MYCOPHENOLATE MOFETIL (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/11/2012 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 66MCE95TEMAZEPAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/18/2011 | 61MCA42LEVETIRACETAM (ANTI-CONVULSANT) | New Orleans District Office (NOL-DO) | |
| 10/18/2011 | 66NCA03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | New Orleans District Office (NOL-DO) | |
| 10/18/2011 | 61NCA77PAROXETINE HCL (ANTI-DEPRESSANT) | New Orleans District Office (NOL-DO) | |
| 12/15/2010 | 62JCA12CABERGOLINE (ANTI-PARKINSONIAN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/6/2009 | 56IIY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/7/2008 | 61PAA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Cobalt Pharmaceuticals, Inc.'s FDA import refusal history?
Cobalt Pharmaceuticals, Inc. (FEI: 3003989770) has 9 FDA import refusal record(s) in our database, spanning from 2/7/2008 to 11/25/2013.
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. Cobalt Pharmaceuticals, Inc.'s FEI number is 3003989770.
What types of violations has Cobalt Pharmaceuticals, Inc. received?
Cobalt Pharmaceuticals, Inc. has been cited for 2 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 Cobalt Pharmaceuticals, Inc. come from?
All FDA import refusal data for Cobalt Pharmaceuticals, 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.