Colgate-palmolive (c.a.) S.a.
⚠️ Moderate Risk
FEI: 3008197908 • Guatemala, Guatemala • GUATEMALA
FEI Number
3008197908
Location
Guatemala, Guatemala
Country
GUATEMALAAddress
Av. Del Ferrocarril 49-65 z. 12, , Guatemala, Guatemala, Guatemala
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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/8/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/20/2017 | 53DD01COLOGNES AND TOILET WATERS (FRAGRANCE PREPARATIONS) | 473LABELING | Division of Southeast Imports (DSEI) |
| 8/5/2014 | 76EFWTOOTHBRUSH, MANUAL | 237NO PMA | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Colgate-palmolive (c.a.) S.a.'s FDA import refusal history?
Colgate-palmolive (c.a.) S.a. (FEI: 3008197908) has 3 FDA import refusal record(s) in our database, spanning from 8/5/2014 to 11/8/2021.
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 (c.a.) S.a.'s FEI number is 3008197908.
What types of violations has Colgate-palmolive (c.a.) S.a. received?
Colgate-palmolive (c.a.) S.a. 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 (c.a.) S.a. come from?
All FDA import refusal data for Colgate-palmolive (c.a.) S.a. 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.