Estimuladores Mexicanos Sa
✅ Low Risk
FEI: 3010908774 • Col Delvalle • MEXICO
FEI Number
3010908774
Location
Col Delvalle
Country
MEXICOAddress
Calle Gabriel Mancera # 718 B, , Col Delvalle, , 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Estimuladores Mexicanos Sa's FDA import refusal history?
Estimuladores Mexicanos Sa (FEI: 3010908774) has 1 FDA import refusal record(s) in our database, spanning from 7/30/2014 to 7/30/2014.
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. Estimuladores Mexicanos Sa's FEI number is 3010908774.
What types of violations has Estimuladores Mexicanos Sa received?
Estimuladores Mexicanos Sa has been cited for 3 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 Estimuladores Mexicanos Sa come from?
All FDA import refusal data for Estimuladores Mexicanos 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.