Colgate Palmolive Canada, Inc.
⚠️ Moderate Risk
FEI: 1000262888 • Mississauga, Ontario • CANADA
FEI Number
1000262888
Location
Mississauga, Ontario
Country
CANADAAddress
6400 Northwest Dr, , 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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/18/2005 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 4/29/2003 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 4/29/2003 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 4/29/2003 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 4/4/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/4/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/4/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2003 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 12/31/2002 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 2/28/2002 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Colgate Palmolive Canada, Inc.'s FDA import refusal history?
Colgate Palmolive Canada, Inc. (FEI: 1000262888) has 10 FDA import refusal record(s) in our database, spanning from 2/28/2002 to 2/18/2005.
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. Colgate Palmolive Canada, Inc.'s FEI number is 1000262888.
What types of violations has Colgate Palmolive Canada, Inc. received?
Colgate Palmolive 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 Colgate Palmolive Canada, Inc. come from?
All FDA import refusal data for Colgate Palmolive 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.