Wyeth Consumer Hea
⚠️ Moderate Risk
FEI: 3004537450 • Mississauga, ON • CANADA
FEI Number
3004537450
Location
Mississauga, ON
Country
CANADAAddress
5975 Whittle Rd 4f, , Mississauga, ON, 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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/23/2013 | 60CAJ09PHENYLEPHRINE HCL (ADRENERGIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/28/2011 | 60QBO69PRAMOXINE HCL (ANESTHETIC) | New York District Office (NYK-DO) | |
| 1/5/2011 | 65QCY22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/5/2011 | 65QDA22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/5/2010 | 65QAA22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/23/2010 | 62GAC41IBUPROFEN (ANTI-INFLAMMATORY) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/16/2010 | 65QIY22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/15/2009 | 60LBB01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 11/6/2009 | 65QDA22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/26/2009 | 60LDA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/21/2009 | 65QDB22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2009 | 65QBB22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/23/2009 | 65QCB22METHOCARBAMOL (RELAXANT) | Detroit District Office (DET-DO) | |
| 9/19/2008 | 60LAB05ASPIRIN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/19/2008 | 60LDA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/27/2008 | 60LBH01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/23/2007 | 65QBP22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2005 | 65QAY22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Wyeth Consumer Hea's FDA import refusal history?
Wyeth Consumer Hea (FEI: 3004537450) has 18 FDA import refusal record(s) in our database, spanning from 3/29/2005 to 1/23/2013.
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. Wyeth Consumer Hea's FEI number is 3004537450.
What types of violations has Wyeth Consumer Hea received?
Wyeth Consumer Hea 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 Wyeth Consumer Hea come from?
All FDA import refusal data for Wyeth Consumer Hea 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.