Dermium Sa De Cv
⚠️ Moderate Risk
FEI: 3010330191 • San Pedro Garza Garcia, Nuevo Leon • MEXICO
FEI Number
3010330191
Location
San Pedro Garza Garcia, Nuevo Leon
Country
MEXICOAddress
Calle Rio Guadalquivir, Col. Jardines Del Valle, San Pedro Garza Garcia, San Pedro Garza Garcia, Nuevo Leon, Mexico
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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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
Frequently Asked Questions
What is Dermium Sa De Cv's FDA import refusal history?
Dermium Sa De Cv (FEI: 3010330191) has 1 FDA import refusal record(s) in our database, spanning from 8/14/2013 to 8/14/2013.
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. Dermium Sa De Cv's FEI number is 3010330191.
What types of violations has Dermium Sa De Cv received?
Dermium Sa De Cv 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 Dermium Sa De Cv come from?
All FDA import refusal data for Dermium Sa De Cv 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.