Colgate Palmolive
⚠️ Moderate Risk
FEI: 3004860449 • Hamburg, Hamburg • GERMANY
FEI Number
3004860449
Location
Hamburg, Hamburg
Country
GERMANYAddress
Lubecker Str. 128, , Hamburg, Hamburg, Germany
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
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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).
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 |
|---|---|---|---|
| 12/5/2011 | 27YGE01CATSUP | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 12/5/2011 | 33EGE06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 12/5/2011 | 33EGE06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 12/5/2011 | 33EGE06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 12/5/2011 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New Orleans District Office (NOL-DO) | |
| 12/5/2011 | 33EGE06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | New Orleans District Office (NOL-DO) | |
| 8/29/2011 | 63RBJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 63RBJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New Orleans District Office (NOL-DO) | |
| 8/29/2011 | 63RBJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Colgate Palmolive's FDA import refusal history?
Colgate Palmolive (FEI: 3004860449) has 9 FDA import refusal record(s) in our database, spanning from 8/29/2011 to 12/5/2011.
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 3004860449.
What types of violations has Colgate Palmolive received?
Colgate Palmolive 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 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.