Colgate Palmolive Company
⚠️ Moderate Risk
FEI: 3003367301 • Boksburg, Gauteng • SOUTH AFRICA
FEI Number
3003367301
Location
Boksburg, Gauteng
Country
SOUTH AFRICAAddress
528 Commissioner Street, , Boksburg, Gauteng, South Africa
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
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2006 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/27/2004 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/27/2004 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/27/2004 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/27/2004 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/18/2003 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/18/2003 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/18/2003 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/29/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) | |
| 8/29/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) | |
| 8/8/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Florida District Office (FLA-DO) | |
| 8/8/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Florida District Office (FLA-DO) | |
| 8/8/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Florida District Office (FLA-DO) | |
| 8/8/2003 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Florida District Office (FLA-DO) | |
| 8/8/2003 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Florida District Office (FLA-DO) | |
| 8/8/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Florida District Office (FLA-DO) | |
| 8/8/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Florida District Office (FLA-DO) | |
| 8/8/2003 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Florida District Office (FLA-DO) | |
| 9/6/2002 | 53IA01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/6/2002 | 53IA01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Colgate Palmolive Company's FDA import refusal history?
Colgate Palmolive Company (FEI: 3003367301) has 41 FDA import refusal record(s) in our database, spanning from 9/6/2002 to 11/7/2006.
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 Company's FEI number is 3003367301.
What types of violations has Colgate Palmolive Company received?
Colgate Palmolive Company 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 Company come from?
All FDA import refusal data for Colgate Palmolive Company 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.