COLGATE PALMOLIVE INDIA LTD
⚠️ Moderate Risk
FEI: 3015726747 • Mumbai, Maharashtra • INDIA
FEI Number
3015726747
Location
Mumbai, Maharashtra
Country
INDIAAddress
Powal, , Mumbai, Maharashtra, India
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/4/2024 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) | |
| 12/4/2024 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) | |
| 11/12/2019 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is COLGATE PALMOLIVE INDIA LTD's FDA import refusal history?
COLGATE PALMOLIVE INDIA LTD (FEI: 3015726747) has 3 FDA import refusal record(s) in our database, spanning from 11/12/2019 to 12/4/2024.
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 INDIA LTD's FEI number is 3015726747.
What types of violations has COLGATE PALMOLIVE INDIA LTD received?
COLGATE PALMOLIVE INDIA LTD has been cited for 6 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 INDIA LTD come from?
All FDA import refusal data for COLGATE PALMOLIVE INDIA LTD 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.