Isp (Mexico) Sa De Cv
✅ Low Risk
FEI: 3005237138 • Col San Miguel • MEXICO
FEI Number
3005237138
Location
Col San Miguel
Country
MEXICOAddress
Francisco Fagoaga 103, , Col San Miguel, , Mexico
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
Frequently Asked Questions
What is Isp (Mexico) Sa De Cv's FDA import refusal history?
Isp (Mexico) Sa De Cv (FEI: 3005237138) has 1 FDA import refusal record(s) in our database, spanning from 10/25/2005 to 10/25/2005.
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. Isp (Mexico) Sa De Cv's FEI number is 3005237138.
What types of violations has Isp (Mexico) Sa De Cv received?
Isp (Mexico) 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 Isp (Mexico) Sa De Cv come from?
All FDA import refusal data for Isp (Mexico) 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.