Colgate Palmolive, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3003679135 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3003679135
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Presa La Angostura 225, Col. Irrigacion, Miguel Hidalgo, Ciudad De Mexico, Ciudad de Mexico, Mexico
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
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.
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
COSMETFPLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/9/2023 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 11/4/2021 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 198COLOR LBLG | Division of Southwest Imports (DSWI) |
| 11/6/2020 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Division of Southwest Imports (DSWI) |
| 2/15/2017 | 53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 2/15/2017 | 53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 11/5/2010 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 11/5/2010 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 11/5/2010 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 11/5/2010 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 7/18/2008 | 53DH03POWDERS (DUSTING AND TALCUM, EXCLUDING AFTERSHAVE TALC) (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 7/18/2008 | 53DD01COLOGNES AND TOILET WATERS (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 3/20/2007 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) | |
| 3/20/2007 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) | |
| 3/20/2007 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) | |
| 4/19/2006 | 62WAJ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Southwest Import District Office (SWI-DO) | |
| 4/12/2006 | 62WAJ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/12/2006 | 63WAJ99DETERGENT N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/12/2006 | 62WAJ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Southwest Import District Office (SWI-DO) | |
| 11/29/2005 | 62WCL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Southwest Import District Office (SWI-DO) | |
| 3/23/2005 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 3/23/2005 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 4/5/2004 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | Southwest Import District Office (SWI-DO) |
| 4/5/2004 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | Southwest Import District Office (SWI-DO) | |
| 2/2/2004 | 53EC07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 2/2/2004 | 53DD01COLOGNES AND TOILET WATERS (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 6/24/2002 | 64ABQ20TRICLOSAN (DISINFECTANT) | Southwest Import District Office (SWI-DO) | |
| 6/24/2002 | 64ABY20TRICLOSAN (DISINFECTANT) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Colgate Palmolive, S.A. de C.V.'s FDA import refusal history?
Colgate Palmolive, S.A. de C.V. (FEI: 3003679135) has 27 FDA import refusal record(s) in our database, spanning from 6/24/2002 to 1/9/2023.
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, S.A. de C.V.'s FEI number is 3003679135.
What types of violations has Colgate Palmolive, S.A. de C.V. received?
Colgate Palmolive, S.A. de C.V. has been cited for 12 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, S.A. de C.V. come from?
All FDA import refusal data for Colgate Palmolive, S.A. de C.V. 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.