Colgate Palmolive Manufacturing Poland SP ZOO
⚠️ Moderate Risk
FEI: 3006535067 • Swidnica, Dolnoslaskie • POLAND
FEI Number
3006535067
Location
Swidnica, Dolnoslaskie
Country
POLANDAddress
Ul. Aleja Colgate 2, , Swidnica, Dolnoslaskie, Poland
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).
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.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/12/2024 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/20/2023 | 62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/19/2020 | 63RBY99DENTAL CARIES PROPHYLACTIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 5/19/2020 | 63RBY99DENTAL CARIES PROPHYLACTIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 5/19/2020 | 63RBY99DENTAL CARIES PROPHYLACTIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 4/23/2020 | 63RCY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) | |
| 8/9/2018 | 63RAY03OLAFLUR (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) | |
| 8/9/2018 | 63RAY03OLAFLUR (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) | |
| 8/5/2015 | 76EFWTOOTHBRUSH, MANUAL | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Colgate Palmolive Manufacturing Poland SP ZOO's FDA import refusal history?
Colgate Palmolive Manufacturing Poland SP ZOO (FEI: 3006535067) has 9 FDA import refusal record(s) in our database, spanning from 8/5/2015 to 3/12/2024.
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 Manufacturing Poland SP ZOO's FEI number is 3006535067.
What types of violations has Colgate Palmolive Manufacturing Poland SP ZOO received?
Colgate Palmolive Manufacturing Poland SP ZOO 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 Manufacturing Poland SP ZOO come from?
All FDA import refusal data for Colgate Palmolive Manufacturing Poland SP ZOO 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.