Laboratorios Sophias Sa De Cv
⚠️ Moderate Risk
FEI: 3004442603 • Guadalajara Jaliscomexico • MEXICO
FEI Number
3004442603
Location
Guadalajara Jaliscomexico
Country
MEXICOAddress
Av Hidalgo 738colonia Centro, , Guadalajara Jaliscomexico, , 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
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 Laboratorios Sophias Sa De Cv's FDA import refusal history?
Laboratorios Sophias Sa De Cv (FEI: 3004442603) has 2 FDA import refusal record(s) in our database, spanning from 4/2/2004 to 2/6/2008.
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. Laboratorios Sophias Sa De Cv's FEI number is 3004442603.
What types of violations has Laboratorios Sophias Sa De Cv received?
Laboratorios Sophias Sa De Cv has been cited for 1 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 Laboratorios Sophias Sa De Cv come from?
All FDA import refusal data for Laboratorios Sophias 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.