Whitehall Robins Inc
⚠️ Moderate Risk
FEI: 1000596246 • Mississauga, Ontario • CANADA
FEI Number
1000596246
Location
Mississauga, Ontario
Country
CANADAAddress
210-5975 Whittle 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2007 | 65QIB22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/30/2006 | 65QAA22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/22/2005 | 65QAY22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2005 | 65QAY22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/23/2003 | 60LBY99ANALGESIC, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Whitehall Robins Inc's FDA import refusal history?
Whitehall Robins Inc (FEI: 1000596246) has 5 FDA import refusal record(s) in our database, spanning from 12/23/2003 to 12/13/2007.
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. Whitehall Robins Inc's FEI number is 1000596246.
What types of violations has Whitehall Robins Inc received?
Whitehall Robins Inc has been cited for 1 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 Whitehall Robins Inc come from?
All FDA import refusal data for Whitehall Robins 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.