Colgate Palmolive
⚠️ Moderate Risk
FEI: 1000330188 • Karachi, Sindh • PAKISTAN
FEI Number
1000330188
Location
Karachi, Sindh
Country
PAKISTANAddress
Lakson Square, Building No. 2, Sarwar, , Karachi, Sindh, Pakistan
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).
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.
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.
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 |
|---|---|---|---|
| 2/15/2019 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 8/8/2011 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/8/2011 | 53IC01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/4/2010 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Colgate Palmolive's FDA import refusal history?
Colgate Palmolive (FEI: 1000330188) has 4 FDA import refusal record(s) in our database, spanning from 11/4/2010 to 2/15/2019.
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 FEI number is 1000330188.
What types of violations has Colgate Palmolive received?
Colgate Palmolive 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 come from?
All FDA import refusal data for Colgate Palmolive 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.