Laboratorios La Fe Sa De Cv
⚠️ Moderate Risk
FEI: 3003426420 • Naucalpanmexico • MEXICO
FEI Number
3003426420
Location
Naucalpanmexico
Country
MEXICOAddress
Juan Sarabia # 25, , Naucalpanmexico, , 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 La Fe Sa De Cv's FDA import refusal history?
Laboratorios La Fe Sa De Cv (FEI: 3003426420) has 1 FDA import refusal record(s) in our database, spanning from 3/7/2002 to 3/7/2002.
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 La Fe Sa De Cv's FEI number is 3003426420.
What types of violations has Laboratorios La Fe Sa De Cv received?
Laboratorios La Fe 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 Laboratorios La Fe Sa De Cv come from?
All FDA import refusal data for Laboratorios La Fe 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.