Colgate Palmolive Ltda
⚠️ Moderate Risk
FEI: 3001008025 • Osasco, Sao Paulo • BRAZIL
FEI Number
3001008025
Location
Osasco, Sao Paulo
Country
BRAZILAddress
Avenida Manoel Pedro Pimentel 101, , Osasco, Sao Paulo, Brazil
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 4/14/2004 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 4/14/2004 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Colgate Palmolive Ltda's FDA import refusal history?
Colgate Palmolive Ltda (FEI: 3001008025) has 2 FDA import refusal record(s) in our database, spanning from 4/14/2004 to 4/14/2004.
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 Ltda's FEI number is 3001008025.
What types of violations has Colgate Palmolive Ltda received?
Colgate Palmolive Ltda has been cited for 3 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 Ltda come from?
All FDA import refusal data for Colgate Palmolive Ltda 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.