Industria Cosmetica Kent SA
⚠️ Moderate Risk
FEI: 3002634517 • Guatemala, Guatemala • GUATEMALA
FEI Number
3002634517
Location
Guatemala, Guatemala
Country
GUATEMALAAddress
Avenida Petapa Zona 12 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
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/2/2009 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/21/2007 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/13/2004 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 12/13/2004 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Industria Cosmetica Kent SA's FDA import refusal history?
Industria Cosmetica Kent SA (FEI: 3002634517) has 4 FDA import refusal record(s) in our database, spanning from 12/13/2004 to 9/2/2009.
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. Industria Cosmetica Kent SA's FEI number is 3002634517.
What types of violations has Industria Cosmetica Kent SA received?
Industria Cosmetica Kent SA has been cited for 2 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 Industria Cosmetica Kent SA come from?
All FDA import refusal data for Industria Cosmetica Kent SA 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.